Administrative Policy and Procedure Policy Number: 300.005
Subject: Sedation Page: 1 of 7
Effective: March 3, 1997 Revised: September 18, 2009
Approved: Signed by Kathy Guyette, VP and Chief Nursing Offcier on 9/18/2009 and orginal filed in Adminsitration.
Signed by Alan Baumgarten, MD., Chief of Staff on 9/18/2009
PURPOSE:
This policy seeks to establish minimum requirements for administering and monitoring sedation for all patients throughout Mission Hospitals. This Administrative Policy of Mission Health System, Inc. ("Mission") is applicable to Mission Hospitals, Memorial and St. Joseph campuses, the Asheville Surgery Center and other locations where services of the hospital are being provided. Site specific sedation guidelines may be more, but not less restrictive than the hospital guidelines, and must conform to requirements that patients with the same health status receive a comparable level of care throughout Mission Hospitals. These standards are intended for patients undergoing a diagnostic or therapeutic procedure. This policy is applicable to all patients undergoing procedures with the intent to receive sedation.
DEFINITIONS:
1. Anxiolysis
A drug-induced state using medications administered by oral and IM routes during which patients respond normally to verbal commands. The guidelines for Sedation outlined in this policy do not apply to anxiolysis.
2. Moderate Sedation/Analgesia (Conscious Sedation)
A drug-induced depression of consciousness during which patients respond purposefully to verbal commands, either alone or accompanied by light tactile stimulation. No interventions are required to maintain a patent airway, and spontaneous ventilation is adequate. Cardiovascular function is usually maintained.
3. Deep Sedation/Analgesia
A drug induced depression of consciousness during which patients cannot be easily aroused but respond purposefully after repeated or painful stimulation. The ability to independently maintain ventilatory function may be impaired. Patients may require assistance in maintaining a patent airway and spontaneous ventilation may be inadequate. Cardiovascular function
Policy # 300.005 – SEDATION Page 2 of 7
is usually maintained. 4. Anesthesia
Consists of general anesthesia and spinal or major regional anesthesia. It does not include local anesthesia. General anesthesia is a drug induced loss of consciousness during which patients are not arousable, even by painful stimulation. The ability to independently maintain ventilatory function is often impaired. Patients often require assistance in maintaining a patent airway, and positive pressure ventilation may be required because of depressed spontaneous ventilation or drug induced depression of neuromuscular function. Cardiovascular function may be impaired.
5. Proceduralist
The person qualified to perform the procedure. This person may be a physician, midlevel provider, or others privileged to perform an invasive procedure or may be a technologist or other personnel qualified to perform the procedure for noninvasive procedures such as chest radiographs, nuclear medicine scans, ultrasound examinations, or MRI’s.
6. Sedationist
The physician or advanced practitioner privileged to perform the sedation.
7. Monitor
Aperson qualifiedto monitor and respond appropriatel y to the patient's response to medication and assist in any supportive or resuscitative measures required. The monitor will not engage in any tasks that would compromise continuous patient monitoring.
EXCLUSIONS:
1. This policy is not intended to address situations in which an anesthesiologist or nurse anesthetist is engaged in the administration of anesthesia/sedation.
2. This policy does not apply to sedation used to secure an airway, for ventilatory management, for pain control, or when sedation is used as chemical restraint in the psychiatric patient.
LOCATION:
Moderate Sedation may be administered in the following primary locations: Emergency Department, Intensive Care Units, Operating Rooms, Asheville Surgery Center, Radiology Department, Cardiac Cath Lab, Echo Lab, Endoscopy Department including mobile endoscopy, and Pediatrics, Pediatric Outpatient, Pediatric Adolescent Unit, Pediatric Intensive Care Unit, Neonatal Intensive Care Unit and Trauma Care Unit.
Secondary locations may be used when the personnel and equipment needed to perform moderate sedation (as outlined in this policy) are present.
Deep Sedation may be administered in adult and pediatric Intensive Care Units, Neonatal Intensive Care Unit, Pediatric Outpatient, Trauma Care Unit, Cardiac Cath Lab, Radiology, and in the
Policy # 300.005 – SEDATION Page 3 of 7
Emergency Department.
PRIVILEGING AND SKILL COMPETENCY:
Practitioners responsible for the administration of moderate and deep sedation will be privileged through the Medical Staff Credentials Committee. This committee, in consultation with Anesthesiology Clinical Services, establishes the credentialing process and criteria.
The RN monitoring the patient during procedures requiring moderate sedation will have BLS certification and will demonstrate satisfactory completion of the sedation learning module.
The RN monitoring the patient during procedures requiring deep sedation will have ACLS certification and will demonstrate satisfactory completion of the sedation learning module.
The person monitoring the pediatric patients during procedures requiring moderate or deep sedation will be a Pediatric Advanced Life Support (PALS) and/or Emergency Nurse Pediatric Course (ENPC) certified RN and will demonstrate successful completion of the pediatric sedation learning module.
PATIENT SELECTION:
1. The need for any short term, therapeutic, diagnostic, or surgical procedure and subsequent use of sedation will remain under the individual practitioner's practice direction.
2. There must be a documented pre-procedure evaluation of the patient prior to any short term therapeutic, diagnostic, or surgical procedure requiring sedation.
A. A medical history and physical must be performed and documented in the medical record prior to procedure or sedation. Minimal content required includes:
§ Examination specific to procedure being performed. § Indications/symptoms for procedure.
§ Auscultation of heart and lungs. § Airway assessment
§ Previous anesthesia/sedation history.
Components of airway assessment include:
• Look for large incisors, large tongue, beard or facial trauma
• Evaluate 3 finger mouth opening, 3 finger from chest to neck and 2 fingers thyroid to floor of mouth
• Mallampati classification
• Obstruction
• Neck Mobility
B. There is to be a reevaluation immediately prior to administration of intravenous medications to determine that the patient is at this time an appropriate candidate for
Policy # 300.005 – SEDATION Page 4 of 7
sedation.
3. Practitioners are encouraged to consult with a member of the Anesthesiology Clinical Service when there is a question regarding the appropriate delivery of sedation.
INFORMED CONSENT:
Informed consent for any short term therapeutic, diagnostic or surgical procedure in which moderate or deep sedation is to be employed will be signed, dated, and timed and will include the risks/benefits/alternatives of sedation as appropriate. The informed consent should read
"(Procedure) with sedation".
MANAGEMENT:
Moderate Sedation
1. The minimum number of personnel for employing moderate sedation shall be two. § The Proceduralist is the person qualified to perform the procedure.
§ The Sedationist is the physician or advanced practitioner privileged to perform moderate sedation. The Sedationist selects and orders the medications to produce sedation.
§ If the Proceduralist is also the Sedationist, then a monitor is needed. § If the Sedationist is not the Proceduralist, then a monitor is not necessary. § The monitor is the person qualified to monitor and respond appropriately to the
patient’s response to medication and assist in any supportive or resuscitative measures required. The monitor will not engage in any tasks that would compromise continuous patient monitoring.
§ The Sedationist and the monitor will be available to the patient from the time of administration of sedation until recovery or until the care of the patient is transferred to personnel performing recovery care.
2. The following minimum equipment must be present and ready for use in the room where moderate sedation is being administered.
A. Oxygen. B. Suction.
C. Emergency airway equipment.
D. Cardiac monitor if indicated by practitioner.
E. Noninvasive blood pressure monitor or manual blood pressure cuff applied.
F. Pulse oximeter applied with audible variable pitch pulse tone and low threshold alarm. G. Code cart with defibrillator must be located in close proximity to the
procedure/sedation area. H. Reversal agents.
3. All patients receiving IV moderate sedation must have a patent IV with continuous administration of IV fluids per practitioner order. Patent saline or heparin locks (INTs) are acceptable for patients with contraindications to IV fluids. IV fluid for resuscitation should be readily available. The need for IV access in patients receiving sedation by any other route of administration shall be determined by the practitioner.
Policy # 300.005 – SEDATION Page 5 of 7
4. The patient's NPO status will be assessed. The recommended guidelines for nonurgent/non emergent procedures is the patient be NPO for a minimum of two (2) hours for clear liquids, six (6) hours for light meal (nonfat, nonmeat, example: toast), and eight (8) hours for other solid food. Infants may have breast milk up to four (4) hours or infant formula up to six (6) hours prior to procedure.
Deep Sedation.
1. The minimum number of personnel for employing deep sedation shall be two. § The Proceduralist is the person qualified to perform the procedure. § The Sedationist is the physician privileged to perform deep sedation. The
Sedationist selects and orders the medications required for deep sedation. § If the Proceduralist is also the Sedationist, then a monitor must be present. § If the Sedationist is not the Proceduralist, then no monitor is required.
§ The monitor is the person competent to monitor and respond appropriately to the patient’s response to medication and assist in any supportive or resuscitative measures required. The monitor will not engage in any tasks that would compromise continuous patient monitoring.
§ The Sedationist and the monitor will be available to the patient from the time of administration of sedation until recovery or until the care of the patient is transferred to personnel performing recovery care.
When Propofol is being administered for deep sedation, the minimum number of personnel shall be three.
If the Sedationist is not the Proceduralist, then one additional monitor is required. The monitor is the person competent to monitor and respond appropriately to the patient’s response to medication and assist in any supportive or resuscitative measures required. The monitor will not engage in any tasks that would compromise continuous patient monitoring.
• If the Sedationist is also the Proceduralist, then two additional persons are required.
One monitor is the person competent to monitor and respond appropriately to the patient’s response to medication and assist in any supportive or resuscitative measures required. The monitor will not engage in any tasks that would compromise continuous patient monitoring.
A second monitor capable of assistance in maintaining a patent airway and supporting respirations in case ventilatory function is impaired. The second monitor may be another physician or may be a respiratory therapist.
2. The following minimum equipment must be available for use where deep sedation is being administered.
A. Oxygen. B. Suction.
C. Emergency airway equipment. D. Cardiac monitor applied.
E. Noninvasive blood pressure monitor or manual blood pressure cuff applied.
F. Pulse oximeter applied with audible variable pitch pulse tone and low threshold alarm. G. Code cart with defibrillator must be located in close proximity to the
Policy # 300.005 – SEDATION Page 6 of 7
procedure/sedation area. H. Reversal agents.
3. All patients receiving IV deep sedation must have a patent IV with continuous administration of IV fluids per practitioner order. Patent saline or heparin locks (INTs) are acceptable for patients with contraindications to IV fluids. IV fluid for resuscitation should be readily available. The need for IV access in patients receiving sedation by any other route of administration shall be determined by the practitioner.
4. The patient's NPO status will be assessed. The recommended guidelines for
nonurgent/non emergent procedures is the patient be NPO for a minimum of two (2) hours for clear liquids, six (6) hours for light meal (nonfat, nonmeat, example: toast), and eight (8) hours for other solid food. Infants may have breast milk up to four (4) hours or infant formula up to six (6) hours prior to procedure.
PROCEDURE MANAGEMENT:
1. A standardized sedation flow sheet will be completed by the monitor for all patients receiving moderate or deep sedation.
2. Documentation on the sedation flow sheet must include: A. Verification that informed consent is signed. B. Weight.
C. NPO status.
D. Prior adverse drug reactions including allergies. E. Premedication.
F. Beginning and end time of procedure.
G. Baseline blood pressure, pulse, respiratory rate, oxygen saturation on room air (unless the patient is receiving oxygen preprocedure), level of consciousness.
H. Name, dose, route, and time of all drugs given. I. Patient response to all medications given. J. Oxygen delivery.
K. Type and amount of IV fluids (if administered).
L. Any adverse drug reactions or significant responses; management and outcome of these events.
3. Minimum monitoring will include: blood pressure, pulse, respiratory rate, oxygen saturation, level of consciousness (cardiac monitoring required for deep sedation). Minimum monitoring must be documented on the flow sheet at least every ten minutes during the procedure for the adult patient; document on the flow sheet at least every five minutes during the procedure for the pediatric patient. When frequent monitoring of blood pressure and pulse interrupt the procedure, those measures will be waived intraprocedure.
POST PROCEDURE MANAGEMENT FOR MODERATE OR DEEP SEDATION:
1. Patients who receive sedation will be monitored post procedure. They will be considered recovered when monitoring shows a return to safe physiological and psychological levels. An equivalent to the Aldrete Scoring System will be used.
Policy # 300.005 – SEDATION Page 7 of 7
2. Any person receiving a reversal agent must be observed for one hour after the last dose of reversal agent.
3. Inpatient monitoring and documentation:
A. Blood pressure, pulse, respirations, oxygen saturation, and level of consciousness at least every fifteen minutes.
B. Observation of any post procedure complications, management of those events, and patient response.
C. Name, dose, time, route and response of any medications given in the post procedure period.
C. Discharge summary and verbal report to nurse caring for patient on patient care unit. Include pre-procedure vital signs and level of consciousness, any problems encountered during or post procedure, total medications given, IV fluid total, and status of IV.
4. Outpatient monitoring and documentation:
A. Blood pressure, pulse, respiration, oxygen saturation, and level of consciousness at least every fifteen minutes.
B. Observation of any post procedure complications, management of those events and patient response.
C. Name, dose, time, route and response of any medications given in the post procedure period.
D. Verbal and written discharge instructions to patient and responsible adult accompanying patient and driving them home to include restrictions following sedation.
PERFORMANCE IMPROVEMENT:
The Chairperson or designee of the Anesthesiology Clinical Service is responsible to oversee the monitoring and evaluation of sedation use. The following data is gathered for review following the administration of sedation:
> Unplanned intubation
> Unplanned admission or transfer to higher level of care
> Administration of reversal agent
> Drop in oxygen saturation to less than 92% not responsive rapidly to oxygen therapy
> Nausea and vomiting
> Unable to complete procedure
> Achieved sedation level deeper than intent
Physician: __________________________________________________________________________________________________ Procedure:__________________________________________________________________ Date/Time:______________________
Practitioner Intent: Minimal/Moderate Sedation
Deep Sedation
This section must be completed by Practitioner Performing Procedure
H & P documented
No history of complications with previous anesthetics/sedation
Indications for Procedure documented
Auscultation of Heart and Lungs
No history of sleep apnea
______________________________________________________________________________________________ ______________________________________________________________________________________________
Airway assessment:
Look for large incisors, large tongue, beard/moustache, or facial trauma None found
Specify findings ________________________________________________________________________ *Evaluate 3 finger mouth opening, 3 fingers from chin to neck, 2 fingers thyroid to floor of mouth
Normal Specify findings ________________________________________________________________________ *Mallampati classification 1 or 2 3 or 4 Obstruction None visible Specify findings ________________________________________________________________________ Neck mobility Normal Specify findings ________________________________________________________________________ * Not applicable for patients < 50 kg or 14 years of age
Re-evaluation by Practitioner prior to administration of medications
I have determined this patient is an appropriate candidate for sedation.
Practitioner Signature ________________________________________ Sedation Evaluation Sheet
MSJ-02385-102-D
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DO NOT WRITE IN MARGIN
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Asshheevviillllee,, NNCC 2288880011 Mission Hospital, Inc.
DRAFT/PROOF DATE: 10-2-09
REVISIONSneeded
APPROVEDby: Owner___________________ Sponsoring Phys(Required)__________________ Pharmacy_________________________________ CDCChairman (if Appl.)____________________ Nurse Council (if Appl.)____________________
PLEASE Interoffice REVISIONS or APPROVAL
The “LEMON” examination of the airway has been validated (1) as a specific and sensitive predictor of a difficult intubation. The four characteristics of the “Look” exam are large incisors, large tongue, beard or moustache, and facial trauma with large incisors being the most predictive of difficult intubation. The exam is summarized below.
(Fig 1 taken from reference 1)
The exam is scored with one point for presence of each of the four “Look” criteria, one for each of the 3-3-2 rule measurements not reaching the minimum required, one for a Mallampati score of 3 or 4, one for
cannot be evaluated. The maximum score is 10, the minimum, zero. Any score above 3 is highly predictive of a difficult intubation.
With respect to pediatric airway examination - E: evaluate the 3-3-2 rule is not valid in children; nor is M: the Mallampati classification. The LON version of the LEMON is still pertinent and should be documented. Scoring has not been validated in the pediatric patient.
1. Can an airway assessment score predict difficulty at intubation in the emergency department? M J Reed1, M J G Dunn1, D W McKeown, Emergency Medicine Journal 2005;22:99-102
doi:10.1136/emj.2003.008771 2005;22;99-102 Emerg. Med. J.
M J Reed, M J G Dunn and D W McKeown
intubation in the emergency department?
Can an airway assessment score predict difficulty at
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ORIGINAL ARTICLE
Can an airway assessment score predict difficulty
at intubation in the emergency department
?
M J Reed, M J G Dunn, D W McKeown
. . . .
See end of article for authors’ affiliations . . . . Correspondence to: Dr M J Reed, Emergency Department, Royal Infirmary of Edinburgh, 51 Little France Crescent, Edinburgh EH16 4SA, UK; mattreed1@hotmail.com Accepted for publication 9 December 2003 . . . .
Emerg Med J2005;22:99–102. doi: 10.1136/emj.2003.008771
Aim:To assess whether an airway assessment score based on the LEMON method is able to predict difficulty at intubation in the emergency department.
Methods:Patients requiring endotracheal intubation in the resuscitation room of a UK teaching hospital between June 2002 and September 2003 were assessed on criteria based on the LEMON method. At laryngoscopy, the Cormack and Lehane grade was recorded. An airway assessment score was devised and assessed.
Results: 156 patients were intubated during the study period. There were 114 Cormack and Lehane
grade 1 intubations, 29 grade 2 intubations, 11 grade 3 intubations, and 2 grade 4 intubations. Patients with large incisors (p,0.001), a reduced inter-incisor distance (p,0.05), or a reduced thyroid to floor of mouth distance (p,0.05) were all more likely to have a poor laryngoscopic view (grade 2, 3, or 4).
Patients with a high airway assessment score were more likely to have a poor laryngoscopic view compared with those patients with a low airway assessment score (p,0.05).
Conclusions:An airway assessment score based on criteria of the LEMON method is able to successfully stratify the risk of intubation difficulty in the emergency department. Patients with a poor laryngoscopic view (grades 2, 3, or 4) were more likely to have large incisors, a reduced inter-incisor distance, and a reduced thyroid to floor of mouth distance. They were also more likely to have a higher airway assessment score than those patients with a good laryngoscopic view.
T
here is a growing trend in the UK for advanced airway management to be performed in the emergency depart-ment (ED) resuscitation room by ED clinicians, rather than anaesthetists. The need for tracheal intubation in the ED may be unpredictable and is often promptly required. When compared with the same procedure performed in the operating room, a higher incidence of airway manage-ment failure has been suggested.1Some 0.01% of patients intubated electively will have an airway management failure compared with an ED rescue cricothyrotomy rate of 1% in the pilot phase of the National Emergency Airway Registry (NEAR) studies.1
It is suggested that patients intubated in the ED have poorer views on laryngoscopy measured by higher Cormack and Lehane scores.2 3
The historical information, physical examination findings, and radiological features associated with a difficult airway are well established. Proposed airway assessment scales vary from the simple, which often fail to address the many factors associated with a difficult airway, to the complex, which are impractical as a clinical tool. None have been shown to be accurate in predicting airway management problems, and none have been assessed in the ED setting. The physical characteristics associated with difficult intubation include obesity,4 6–8 10 12 head and neck movement,4 6 8–12jaw
move-ment,4 6 receding mandible,4 6 7 11 buck teeth (long upper
incisors),4 6 12 Mallampatti scores,5 6 8–12 maxillary incisor
characteristics,7 male sex,8 age 40–59,8 decreased mouth
opening,8 10–12shortened thyromental distance,5 8–11and short
neck.7Multivariate analysis has been used to quantify the
relative role of each of these physical characteristics.10–12
An assessment system that objectively measures factors associated with a difficult intubation in the resuscitation room needs to be simple to perform, suitable to perform on obtunded and/or non-compliant patients, and easily remem-bered. All of the above systems fail to be suitable when applied in an ED setting.
The US National Emergency Airway Management Course has addressed this issue by devising the LEMON method (fig 1).1
This assessment system includes most of the characteristics discussed above and has been adapted for use in a resuscitation room setting. The LEMON method has not however been validated as a reflection of difficult intubation in the ED.
The aim of this study was therefore to assess whether an airway assessment score based on the LEMON method is able to predict difficulty at intubation in the ED.
METHOD
This was a prospective observational study conducted in the ED of a UK teaching hospital between June 2002 and September 2003. All patients who entered one of the department’s resuscitation rooms underwent an airway assessment according to the LEMON method (fig 1). They were assessed on four ‘‘look’’ criteria, three ‘‘evaluate’’ criteria, the presence of airway obstruction, and neck mobility. Mallampatti class13
was also recorded if possible. Only four of the seven ‘‘look’’ characteristics originally described in the LEMON method were assessed: ‘‘abnormal facial shape’’ was thought to be too subjective, ‘‘protruding teeth’’ is duplicated by the ‘‘large incisor’’ characteristic, and ‘‘false teeth’’ is often difficult to assess adequately. If intubation was performed as part of the patient’s routine clinical management, the grade of intubation was recorded according to Cormack and Lehane scores.14
For the purposes of this study, an easy intubation was defined as a Cormack and Lehane laryngoscopy grade 1 view, and a difficult intubation was defined as a Cormack and Lehane laryngo-scopy grade 2, 3, or 4 view (see Discussion). If an initial intubation attempt was unsuccessful, the grade of laryngo-scopy on the eventual successful attempt was used to define the difficulty of intubation.
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An airway assessment score was calculated as follows. The number of positive ‘‘look’’ criteria was calculated. One point was added for each unfavourable ‘‘evaluate’’ criteria (mouth opening less than three finger breadths, hyo-mental distance less than three finger breadths, or a thyro-hyoid distance less than two finger breadths). One point was also added for a Mallampatti score of 3 or more, for an obstructed airway, and for poor neck mobility. If a test could not be performed the patient received a score of zero for that criterion. The maximum airway assessment score possible was therefore 10 and the minimum zero.
All data were entered on a form and completed forms were collected for data entry and analysis using Microsoft Excel. Fisher’s exact test was used to compare categorical variables and Student’s t test for parametric data. Spearman’s rank sum test was used to assess correlation between categorical variables. Significance was defined as p,0.05.
RESULTS
Between June 2002 and September 2003, 156 patients who were intubated in the ED were entered into the study. This comprised 88% of the 177 patients undergoing intubation in the department during this period. Patients who were lost from the study did not have a formal airway assessment
performed at the time of intubation. All 156 patients were successfully intubated in the ED.
Altogether 114 patients were characterised as Cormack and Lehane grade 1 and 42 were classed as Cormack and Lehane grades 2, 3, or 4 (grade 2 = 29, grade 3 = 11, and grade 4 = 2). Table 1 compares the characteristics of patients with an easy intubation (grade 1) compared with those with a difficult intubation (grades 2, 3, and 4).
There was no significant difference in the sex ratios (M/F) between the two groups (75/39 compared with 32/10, p = 0.25, NS). There was also no difference in mean age between the two groups (53.8 years compared with 55.7 years, p = 0.86, NS).
Of the three ‘‘look’’ criteria of the LEMON method, only patients with large incisors (p,0.001) were more likely to have a difficult intubation (grade 2, 3, or 4). There was no difference in intubation grade in patients with facial trauma (p = 1.0, NS), a beard or moustache (p = 0.49, NS), or a large tongue (p = 0.49, NS). Of the three ‘‘evaluate’’ criteria, both a reduced inter-incisor distance (p,0.05) and a reduced thyroid to floor of mouth distance (p,0.05) were associated with a difficult intubation. There was no significant diffe-rence in intubation grade in patients with a reduced hyoid to chin distance (p = 0.34, NS) however 45.8% of patients in the
L Look externally
Look at the patient externally for characteristics that are known to cause difficult laryngoscopy, intubation or ventilation.
E Evaluate the 3-3-2 rule
In order to allow alignment of the pharyngeal, laryngeal and oral axes and therefore simple intubation, the following relationships should be observed. The distance between the patient's incisor teeth should be at least 3 finger breadths (3), the distance between the hyoid bone and the chin should be at least 3 finger breadths (3), and the distance between the thyroid notch and the floor of the mouth should be at least 2 finger breadths (2).
1 2 3 = = =
Inter-incisor distance in fingers. Hyoid mental distance in fingers. Thyroid to floor of mouth in fingers.
O Obstruction?
Any condition that can cause obstruction of the airway will make laryngoscopy and ventilation difficult. Such conditions are epiglottis, peritonsillar abscesses and trauma.
N Neck mobility
This is a vital requirement for successful intubation. It can be assessed easily by getting the patient to place their chin down onto their chest and then to extend their neck so they are looking towards the ceiling. Patients in hard collar neck immobilization obviously have no neck movement are therefore harder to intubate.
M Mallampati
The hypopharynx should be visualized adequately. This has been done traditionally by assessing the Mallampati classification. The patient is sat upright, told to open the mouth fully and protrude the tongue as far as possible. The examiner then looks into the mouth with a light torch to assess the degree of hypopharynx visible. In the case of a supine patient, Mallampati score can be estimated by getting the patient to open the mouth fully and protrude the tongue and a laryngoscopy light can be shone into the hypopharynx from above.
Class I: soft palate, uvula, fauces, pillars
visible
Class II: soft palate, uvula, fauces visible
Class III: soft palate, base of uvula visible
Class IV: hard palate only visible 1
2 3
Figure 1 The LEMON airway assessment method.
100 Reed, Dunn, McKeown
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difficult intubation group had a reduced hyoid to chin distance compared with only 34.2% in the easy intubation group.
There was also no significant association between an increased Mallampatti score, the presence of airway obstruc-tion, or the presence of limited neck mobility and a difficult intubation. Patients with a difficult intubation were more likely to have an obstructed airway (14.3% versus 6.5%) and reduced neck mobility (28.6% versus 16.2%) although this did not reach significance.
Table 2 and figure 2 compare the airway assessment scores for the two intubation difficulty groups. Patients in the difficult intubation group had a significantly greater airway assessment score compared with patients in the easy intu-bation group (p,0.05). There was also a positive correlation between airway assessment score and intubation grade
(r= 0.38, p,0.001). Median airway assessment score for the easy intubation groups was 1.0 (interquartile range 0– 2.0) compared with 2.0 (interquartile range 0.3–3.0) in the difficult intubation group.
DISCUSSION
This is the first published study that has attempted to validate the LEMON method in the ED population. We have shown that an airway assessment score based on the LEMON method is able to stratify the risk of intubation difficulty in this population. We have also shown that ED patients with certain airway characteristics are also more likely to have a poor laryngoscopic view. Patients with large incisors, a reduced mouth opening, and a reduced thyroid to floor of mouth distance are all more likely to have a poor view at laryngoscopy. Patients with a reduced hyoid to chin distance, airway obstruction, and reduced neck mobility all have a trend towards poor views, however these factors did not
Table 1 Summary of results
Characteristic
Easy intubation
group Number
Difficult intubation
group Number p Value
Number of patients 114 — 42 — — Sex ratio (M/F) 75/39 114 32/10 42 0.25 NS Male percentage 65.8 76.2 Mean (SD) Mean (SD) Age 53.8 (23.2) 114 55.7 (18.7) 42 0.86 NS` Look % % Facial trauma 11.3 106 12.2 41 1.0 NS Large incisors 6.5 108 28.6 42 ,0.001* Beard or moustache 6.3 111 9.8 41 0.49 NS Large tongue 1.0 104 2.4 41 0.49 NS Evaluate % % Incisor distance 3+ 61.8 76 31.0 29 ,0.05* Incisor distance,3 38.2 69.0
Hyoid / mental dist 3+ 65.8 76 54.2 24 0.34 NS Hyoid / mental dist,3 34.2 45.8
Thyroid to mouth 2+ 86.6 82 58.3 24 ,0.05* Thyroid to mouth,2 13.4 41.2 Mallampatti % % Grade 1 or 2 67.2 67 78.9 19 0.41 NS Grade 3 or 4 32.8 21.1 Obstruction % % Obstructed airway 6.5 108 14.3 42 0.19 NS Neck mobility % % In collar/limited 16.2 105 28.6 42 0.11 NS Full and free 83.8 71.41
*Significance accepted at the level of 0.05 = 5%; NS, non-significant.Fisher’s exact test (two tailed);`Student’s ttest (two tailed).
50 45 35 40 30 20 25 15 10 0 5 7 Airway score Number of patients 6 5 4 3 2 1 Easy intubation Difficult intubation
Figure 2 Graph showing number of patients with each airway assessment score in both intubation difficulty groups.
Table 2 Airway assessment scores for the two intubation difficulty groups Airway assessment score Easy intubation group Difficult intubation group p Value Number % Number % 0 43 38 11 26 1 28 25 7 17 2 26 23 9 21 3 10 9 5 12 4 6 5 7 17 5 1 1 1 2 6 0 0 2 5 7 0 0 0 0 8 0 0 0 0 9 0 0 0 0 10 0 0 0 0 Total 114 100 42 100 Median 1.0 2.0 IQ range 0–2.0 0.3–3.0 p,0.05* *Significance accepted at the level of 0.05 = 5%.Fisher’s exact test (two tailed).
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reach significance in this study. A study looking at a larger population may show that these factors are also associated with poor laryngoscopic views.
This study has several limitations. The airway manager performing the LEMON assessment also performed the intu-bation procedure. This may have led to bias in the subsequent recording of the LEMON characteristics or intubation grade. To assess a large number of intubations, the study aimed to include all intubations carried out in the ED. This could have led to interobserver variability when recording the LEMON characteristics. For example, an inter-incisor distance is measured in finger breadths, which are in turn dependent on the person conducting the test. Other characteristics prone to subjectivity are those of the ‘‘look’’ assessment. Clearly the assessment of a rather vague term such as ‘‘large incisors’’ is highly subjective and is prone to significant interobserver variability. We do not deny that this is the case, however the LEMON method includes the assessment of such character-istics and is designed to be a quick and easy assessment tool. To include complex definitions for such characteristics would defeat the purpose of such a simple, easily remembered ED airway assessment tool. Three ‘‘look’’ characteristics origin-ally described in the LEMON method were removed for this study (see Methods) for similar reasons.
We have defined intubation difficulty based on scores at laryngoscopy. We recognise that laryngoscopic view may be a separate issue to intubation difficulty. Other factors such as the number of separate laryngoscopy attempts made, the length of laryngoscopy attempts, and the number and senio-rity of airway managers involved have also been described as markers of a difficult intubation.12
We chose not to look at these other markers because of their many confounding factors (for example, operator experience), however they could be assessed in future studies.
We have already shown in a previous study that the ‘‘look’’, ‘‘obstruction’’, and ‘‘neck mobility’’ components of the LEMON method are easily assessed in the resuscitation room population.15 ‘‘Evaluate’’ criteria could only be fully
assessed in 90% of the resuscitation room population and ‘‘Mallampatti’’ was even less easily assessed being possible in only 57% of patients.
As we have shown that ‘‘Mallampatti’’ is both difficult to assess and a poor predictor of intubation grade in the ED, it probably has little place in an ED airway assessment score. ‘‘Evaluate’’ criteria are more easily assessed and seem to be predictive of a difficult intubation in the ED population.
We suggest that a LEMON method based airway assess-ment score (table 3) based on four of the five criteria of the LEMON method (all except ‘‘Mallampatti’’), should be routinely used in the ED to highlight a potentially difficult airway. Use of this score would encourage airway managers to conduct a thorough systematic evaluation of the airway and to readily anticipate problems in its management. If difficulty was predicted early, then more senior help with advanced airway management could be sought.
In conclusion, an airway assessment score based on criteria of the LEMON method is able to successfully stratify the risk of difficult intubation in the emergency department. Patients with a poor laryngoscopic view (grades 2, 3, or 4) were more likely to have large incisors, a reduced inter-incisor distance, and a reduced thyroid to floor of mouth distance. They were also more likely to have a higher airway assessment score than those patients with a good larygoscopic view.
CONTRIBUTORS
Matthew Reed: literature search, study design, interpretation of results, principal investigator, data entry, analysis and reporting of data, writing the paper. Mark Dunn: data collection, data entry, and revision of paper. Dermot McKeown: original idea, literature search, study design, project supervision, and revision of paper.
Authors’ affiliations . . . .
M J Reed, M J G Dunn,Emergency Department, Royal Infirmary of Edinburgh, Edinburgh, UK
D W McKeown,Anaesthetic Department, Royal Infirmary of Edinburgh Funding: none.
Conflicts of interest: none declared.
REFERENCES
1 Murphy MF, Walls RM. The difficult and failed airway. In:Manual of emergency airway management. Chicago: Lippincott Williams and Wilkins, 2000:31–9.
2 MacKay CA, Terris J, Coats TJ. Prehospital rapid sequence induction by emergency physicians: is it safe?Emerg Med J2001;18:20–4. 3 Graham CA, Beard D, Oglesby AJ,et al.Rapid sequence intubation in
Scottish urban emergency departments.Emerg Med J2003;20:3–5. 4 Wilson ME, Spiegelhalter D, Robertson JA,et al.Predicting difficult intubation.
Br J Anaesth1988;61:211–16.
5 Frerk CM. Predicting difficult intubation.Anaesthesia1991;46:1005–8. 6 Oates JDL, Macleod AD, Oates PD,et al.Comparison of two methods of
predicting intubation difficulty.Br J Anaesth1991;66:305–9. 7 Rocke DA, Murray WB, Rout CC,et al.Relative risk analysis of factors
associated with difficult intubation in obstetric anesthesia.Anesthesiology 1992;77:67–73.
8 Rose DK, Cohen MM. The airway. Problems and prediction in 18500 patients. Can J Anaesth1994;41:372–83.
9 Tse JC. Rimm EB. Hussain A. Predicting difficult endotracheal intubation in surgical patients scheduled for general anesthesia: a prospective blind study, Anesth Analg1995;81:254–8.
10 el-Ganzouri AR, McCarthy RJ, Tuman KJ,et al.Preoperative airway assessment: predictive value of a multivariate risk index.Anesth Analg 1996;82:1197–204.
11 Arne J, Descoins P, Fusciardi J,et al.Preoperative assessment for difficult intubation in general and ENT surgery: predictive value of a clinical multivariate risk index.Br J Anaesth1998;80:140–6.
12 Saghaei M, Safavi MR. Prediction of prolonged laryngoscopy.Anaesthesia 2001;56:1181–201.
13 Mallampatti SR, Gatt SP, Gugino LD,et al.A clinical sign to predict difficult intubation: a prospective study.Can Anaesth Soc J 1985;32:429–34.
14 Cormack RS, Lehane J. Difficult intubation in obstetrics.Anaesthesia 1984;39:1105–11.
15 Reed MJ, Rennie LM, Dunn MJG,et al.Is the ‘LEMON’ method an easily applied emergency airway assessment tool?European Journal of Emergency Medicine2004;11:154–7.
Table 3 Proposed revised LEMON based airway
assessment score
Airway assessment score Points Number of positive unfavourable ‘‘look’’ criteria
0–4 points Mouth opening less than three finger breadths
1 point Hyo-mental distance less than three finger breadths
1 point Thyro-hyoid distance less than two finger breadths
1 point Presence of an obstructed airway 1 point Presence of poor neck mobility 1 point
Total:maximum airway assessment score = 9, minimum = zero
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NORTH CAROLINA BAPTIST HOSPITALS POLICY AND PROCEDURE BULLETN
PREPARED BY: Dr. Jeff Kelly
Dr. Raymond C. Roy
CONTACT PERSON: Director of Surgical Services
SUBJECT: Administration of Sedatives and Analgesics by Non-Anesthesiologist Attending Physicians During Diagnostic and Therapeutic Procedures
I. POLICY
This policy refers to the administration of sedatives and/or analgesics under the medical direction of non-anesthesiologist attending physicians to patients undergoing invasive, constraining, or
manipulative procedures in patient care areas outside of the Operating Room.
II. PURPOSE
The purpose of this policy is to ensure a comparable level of care for all patients receiving sedation and analgesia during procedure performance in patient care areas not routinely staffed by members of the Department of Anesthesiology and to improve patient outcomes in such areas.
III. DEFINITIONS
A. Minimal sedation (anxiolysis) – a drug-induced state during which patients respond normally to verbal commands. Although cognitive function and coordination may be impaired, ventilatory and cardiovascular functions are unaffected.
B. Moderate sedation/analgesia (“conscious sedation”) – a drug-induced depression of
consciousness during which patients respond purposefully to verbal commands, either alone or accompanied by light tactile stimulation. No interventions are required to maintain a patent airway, and spontaneous ventilation is adequate. Cardiovascular function is usually maintained. C. Deep sedation/analgesia – a drug-induced depression of consciousness during which patients
cannot be easily aroused, but respond purposefully following repeated or painful stimulation. The ability to independently maintain ventilatory function may be impaired. Patients may require assistance in maintaining a patent airway, and spontaneous ventilation may be inadequate.
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D. General anesthesia – a drug-induced depression of consciousness during which patients are not arousable, even by painful stimulation. The ability to independently maintain ventilatory function is often impaired. Patients often require assistance in maintaining a patent airway, and positive pressure ventilation may be required because of depressed spontaneous ventilation or drug-induced depression of neuromuscular function. Cardiovascular function may be impaired. General anesthetic care is not covered by the terms of this policy and should only be administered by trained individuals with appropriate anesthesia credentials.
While this policy is intended to be widely applicable, broad in scope, and fulfill the needs of most affected clinical areas, it may not be completely appropriate for some areas due to variables such as patient population, specific procedure demands, and/or attending physician experience/preference. In such circumstances, affected areas must develop an individual area-specific sedation/analgesia policy using this policy as their guide for minimal acceptable standards. Any area-specific policies so developed must contain strong evidence-based literature support justifying any deviations from this policy including, but not limited to (1) policy statements and/or practice guidelines independently developed by the appropriate national specialty organization and/or (2) satisfactory outcome data published in the appropriate specialty’s national journal. Approval of such area-specific policies by both the Conscious Sedation Committee (which includes the Chairman of the Department of
Anesthesiology) and the Chief of Professional Services will be required prior to their implementation.
IV. POLICY APPLICABILITY
This policy is applicable to the following areas and/or circumstances: A. Location:
Sedation and analgesia is practiced in various areas within the Institution including, but not limited to the (1) Emergency Department, (2) Radiology Department, (3) MRI suite, (4)
Bronchoscopy/Endoscopy suite, (5) Electrophysiology Laboratory, (6) Cardiac Catheterization suite, and (7) Clinical Ultrasound.
B. Medications and dosages:
Implementation of and compliance with the terms of this policy is mandatory whenever: (1) hourly dosages of a single sedative or analgesic agent exceed the age-specific thresholds
summarized in Appendix 1 of this policy.
(2) any combination of sedatives and analgesics in any dosage are administered. (3) nitrous oxide in concentrations up to 40% and mixed with oxygen is
combined with another sedative and/or analgesic by another route of administration.
This policy is not applicable to the following areas and/or circumstances: A. credentialed members of the Department of Anesthesiology;
B. all areas designated by the institution as critical care areas;
C. use of intravenous benzodiazepines for the acute treatment/control of tonic-clonic seizures; D. use of clinically appropriate doses of narcotics for analgesia in the setting of painful underlying
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E. use of clinically appropriate doses of oral benzodiazepines for indications such as minimal sedation/anxiolysis, claustrophobia, seizure prophylaxis, delirium tremens treatment/prophylaxis, and/or hypnotic to aid sleep;
F. use of nitrous oxide inhalation analgesia in concentrations up to 40% and mixed with oxygen in the absence of concurrent sedative and/or analgesic use by another route of administration; and G. general inpatient pediatric units covered by the Pediatric Sedation Service of the Department of
Anesthesiology.
Intravenous anesthetic induction agents (such as thiopental, methohexital, etomidate, ketamine, and propofol) and concentrations of nitrous oxide above 40% have such an extremely narrow margin of safety and/or unique side effect profile that this policy expressly forbids their administration for sedation and analgesia except as follows:
A. use for rapid sequence intubation under the medical direction of Emergency Department attending physicians in a manner consistent with that area’s policies and procedures;
B. use of intravenous methohexital in the Electrophysiology Laboratory under the medical direction of Section on Cardiology attending physicians in a manner consistent with that area’s policies and procedures; or
C. ketamine administration in children as detailed in Appendix 1.
V. PROCEDURE
A. Facilities and equipment:
Each clinical area where sedation and analgesia is administered, or where the recovery from sedation and analgesia occurs, must have at least the following minimal equipment present and in working order:
(1) cardiac monitor with alarm capabilities. (2) pulse oximeter with alarm capabilities.
(3) blood pressure measurement (oscillometric or auscultatory).
(4) suction capabilities with appropriate devices, attachments, and tubing.
(5) an oxygen source (either a 50 psi wall outlet or an “E” cylinder capable of delivering a 15 1/min inspiratory flow rate for at least 30 minutes).
(6) a self-inflating reservoir bag-valve-mask system capable of both supporting ventilation as well as delivering > 90% oxygen concentration at the above inspiratory flow rates.
An emergency cart containing basic/advanced airway equipment, a full complement of population-appropriate resuscitation drugs (including the reversal agents naloxone and
flumazenil), and a monitor-defibrillator-pacemaker must be immediately available to resuscitate any patient suffering clinically significant cardiorespiratory compromise from sedative and/or analgesic administration. All areas must document that such resuscitation equipment has been checked and maintained on a regularly scheduled basis to ensure proper performance consistent with the current Medical Center Code Blue Plan. Each area should also have (a) current, age-appropriate resuscitation algorithms (ACLS and/or PALS), (b) a summary of age-age-appropriate naloxone and flumazenil doses, and (c) a mechanism to emergently mobilize either the
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Department of Anesthesiology and/or the Medical Center code team to assist with resuscitative efforts (appendices 2 and 3).
B. Personnel:
The minimum number of health care providers attending the patient receiving sedation and analgesia shall be two, i.e., the licensed independent practitioner (LIP) (defined as the attending physician of record performing the procedure/diagnostic study) and a second designated, properly trained monitoring provider who is not involved in procedure performance.
The LIP is responsible for the overall management of the patient receiving sedation and analgesia as a component of the planned procedure as well as for supervising the monitoring provider simultaneously attending the patient. The LIP will be credentialed in the appropriate
administration of sedation and analgesia under the terms of Medical Center Policy PPB-MSS-01, Credentialing and Recredentialing of Non-Anesthesiologist Attending Physicians for Use of Sedation and Analgesia During Painful, Constraining, or Manipulative Procedures.
The monitoring provider attending the patient during the procedure under sedation and analgesia is responsible for continuously monitoring and documenting at frequent intervals the patient’s clinical and physiologic status. Such monitoring providers should fulfill no additional functions during procedure performance except for brief, minor, interruptible tasks in patients with stable sedation/analgesia levels and vital signs. Monitoring providers will be credentialed in the appropriate care of patients receiving sedation and analgesia using the North Carolina Baptist Hospital’s Competency Assessment for Nurses Delivering Conscious Sedation credentialing tool. A licensed practical nurse (LPN) who satisfactorily fulfills the terms of this competency
assessment may serve as the monitoring provider when directly supervised by an appropriately credentialed registered nurse (RN) who is in close physical proximity to the procedure/diagnostic study.
C. Preprocedure history and physical examination:
In compliance with medical staff rules and regulations, all patients undergoing procedures under sedation and analgesia must receive a preprocedure evaluation focusing on major organ systems to assess their current overall medical condition and determine if they are a suitable
sedation/analgesia candidate. While components of this required preassessment may be delegated to appropriately trained lower level health care providers, the LIP is ultimately
responsible for confirming the accuracy of all information so collected. Such responsibility must be documented by the LIP’s signature in the preassessment area on page 1 of form 09-01760, Sedative/Analgesic Administration for Diagnostic and Therapeutic Procedures.
The preassessment history should include at least:
(1) a review of any pertinent medical records as appropriate.
(2) a brief past medical history and review of systems, with specific emphasis on the cardiovascular, respiratory, airway, and central nervous systems.
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(4) drug allergies/adverse reactions and any specific clinical manifestations. (5) previous responses to sedatives, analgesics, and/or anesthesia.
(6) history of tobacco, alcohol, or illicit drug use.
(7) fasting history (refer to appendix 4 for appropriate duration). (8) the possibility of pregnancy in women of child-bearing age. (9) the results of any pertinent diagnostic studies.
The physical exam should be similarly tailored and include at least: (1) height and weight
(2) baseline blood pressure, pulse, respiratory rate, and pulse oximetry measurements. (3) an assessment of baseline mental status and level of consciousness.
(4) airway exam.
(5) cardiac and pulmonary exams.
The history and physical exam in pediatric patients should, in addition, evaluate for specific or unique pediatric conditions which potentially increase a given infant/child’s risk for complications from sedation and analgesia. Specific examples include, but are not limited to:
(1) congenital heart disease (especially cyanotic).
(2) bronchopulmonary dysplasia and/or home oxygen use.
(3) dysmorphic facies predisposing to airway obstruction and/or difficult bag-valve-mask ventilation.
(4) significant developmental delay, mental retardation, or autism.
(5) prematurity (< 37 weeks gestation or < 60 weeks post-gestational age). (6) full term newborns < 44 weeks gestation.
Infants in either (5) or (6) above must be monitored for at least 12 hours post-procedure because of an increased risk profile for episodic apnea and bradycardia.
An independent evaluation by a member of the Department of Anesthesiology should be considered if concerns arise regarding unusual risk profiles identified by history and physical examination in a given patient.
D. Informed Consent
Following the history and physical examination, the patient or guardian should be informed about the risks, benefits, and alternatives to sedation and analgesia as a component of the planned procedure. Such informed consent must be appropriately documented in the patient’s permanent medical record using form SR-8019, Sedative/Analgesic Administration by Non-Anesthesiologists for Diagnostic and Therapeutic Procedures Consent Form.
E. Patient Monitoring
All patients receiving sedation and analgesia must be continuously monitored during the
procedure by a designated, properly trained monitoring provider under the medical direction and supervision of the LIP. Such monitoring shall include at least:
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(1) An assessment of mental status and level of consciousness. Ideally, this should consist of appropriate verbal responses to simple verbal commands (which imply a patent airway, adequate cerebral perfusion, and acceptable oxygenation). In circumstances where verbal responses are not feasible due to procedure- or patient-specific factors, an appropriate motor response to verbal commands or light physical stimulation (such as “open your eyes”, “take a deep breath”, “wiggle your toes”, or “give me a thumbs up if you’re OK”) represents an acceptable alternative.
(2) An assessment of oxygenation. There should be adequate ambient illumination and patient exposure if possible to visually monitor for the development of cyanosis. Mental status should be frequently assessed as in (1) above. Oxygen saturation by pulse oximetry using appropriate alarm thresholds must be measured frequently and its continuous use is strongly recommended, particularly under suboptimal lighting conditions. The use of supplemental oxygen is strongly encouraged where clinically indicated and/or technically feasible.
(3) An assessment of ventilation. The patient should be frequently evaluated for clinical signs of adequate ventilation, including such parameters as respiratory rate, chest excursion, breath sound auscultation, airway position/patency, absence of accessory muscle use, and/or
intermittent arterial blood gas analysis (for example, during cardiac catheterization). Because oxygenation and ventilation are distinctly separate (though related) physiologic processes, pulse oximetry does not monitor for the adequacy of ventilation under any circumstances. Measurement of exhaled carbon dioxide concentration by capnography should be considered in areas where the specific patient population would support its cost-effective utilization. (4) An assessment of circulation. Blood pressure and pulse rate must be measured at regular
intervals. Continuous ECG monitoring is recommended where feasible and should be routinely performed in all patients with a history of significant cardiovascular disease or risk factors for same (such as hypertension, diabetes, and/or lipid disorders). Because of magnet-induced artifact and the risk of electrode-related thermal injury, ECG monitoring will not be mandatory in patients undergoing MRI imaging under sedation and analgesia. However, ECG monitoring capability must be available for immediate use in the MRI suite should clinical concern arise regarding the patient’s circulatory status.
Compliance with the above monitoring guidelines during certain diagnostic studies where immobility is critical for optimal results may be impractical and disruptive to the point of invalidating the study’s results. Minimal monitoring guidelines in such circumstances must consist of continuous pulse oximetry combined with the clinical parameters (color, respiratory rate, chest excursion, capillary refill, peripheral pulse palpation, etc.) noted above. Continuous ECG monitoring as an alternative to blood pressure measurement under such conditions is strongly encouraged where feasible. In all such circumstances, a blood pressure cuff must be applied to the patient and available for immediate use should clinical concern arise regarding the patient’s circulatory status.
The above monitoring parameters must be documented at regular intervals and become a permanent part of the patient’s medical record. At a minimum, such information must be documented at least (a) baseline prior to sedative/analgesic administration, (b) after establishment of sedation and analgesia, but prior to beginning the planned procedure, (c) at least every 15 minutes during
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documentation includes (a) intravenous access (size, site, amount and type of fluid administered), (b) medications administered (specific agents, doses, times), and (c) use of any supplemental oxygen (delivery system, inspired concentration, 1/min flow rate). Such intraprocedure documentation should be appropriately placed on page 1, section (7) of form 09-01760, Sedative/Analgesic Administration for Diagnostic and Therapeutic Procedures.
F. Patient Recovery
Following completion of the procedure (such as removal of the TEE probe/endoscope, release of radiologic Velcro restraints, appropriate puncture site pressure/dressing application, etc.), all patients shall undergo a recovery period specific to their individual needs to ensure there has been an acceptable return to the presedation/analgesia condition. Such recovery may occur either in the procedure area itself or in a physically separate, comparably equipped recovery area staffed by appropriately trained monitoring providers (as noted under Personnel above). The recovery area must be located such that physician presence is immediately available should complications related to the procedure and/or sedation and analgesia occur. Any patient transported to a separate designated recovery area must be accompanied and continually evaluated by a properly trained monitoring provider. In most circumstances, this will be the same individual who also monitored the patient during the procedure. Upon arrival in the recovery area, the patient should be immediately reassessed and relevant information regarding the patient’s history, physical, current condition, and responses during the procedure transmitted to the monitoring individual assuming recovery care of the patient. Clinical and physiologic parameters should be identically monitored during recovery as they were during the procedure (see Patient Monitoring above) and must be documented at least (a) at the beginning of the recovery period, (b) at least every 15 minutes during recovery, and (c) immediately prior to discharge. Additional required recovery documentation includes (a) intravenous access (size, site, amount and type of fluid administered), (b) medications administered (specific agents, doses, times), and (c) use of any supplemental oxygen (delivery system, inspired concentration, 1/min flow rate). Such recovery documentation should be appropriately placed on page 2 of form 09-01760, Sedative/Analgesic Administration for Diagnostic and Therapeutic Procedures. All patients who receive pharmacologic reversal with either flumazenil and/or naloxone at any point during their care continuum must be monitored for a minimum of one hour after reversal drug administration and reassessed for possible rebound sedation.
G. Patient Discharge
After the patient’s level of consciousness and vital signs are documented to have consistently returned to their pre-procedure status, the LIP is responsible for patient discharge either to a hospital area or home as appropriate. For any patient transferred to another patient care area within the Institution, relevant information regarding the patient’s history, physical, current condition, and responses during the procedure should be verbally transmitted to the admitting floor nurse assuming ongoing care of the patient. Patients being discharged home must be capable of adequate oral or enteral intake, sitting unaided, and ambulating with minimal
assistance (if ambulatory prior to the procedure and assuming no procedural contraindications to ambulation). All outpatients must be discharged to the care of a competent adult who accepts
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responsibility for driving the patient home as well as observing and reporting any post-procedure complications. This responsible caretaker will be given written and verbal instructions
including, but not limited to (a) diet, (b) medications, (c) acceptable and unacceptable activities, (d) signs and symptoms of complications specific to the procedure, (e) signs and symptoms of complications related to sedation and analgesia, and (f) course of action to take and a 24 hour phone number to call should any complications arise. Such recovery documentation should be appropriately placed on pages 2 and 3 of form 09-01760, Sedative/Analgesic Administration for Diagnostic and Therapeutic Procedures.
VI. OUTCOME EVALUATION
All patient care areas where procedure-related sedation and analgesia is administered by
non-anesthesiologists shall monitor patient outcomes by extracting appropriate patient data (as detailed in the Conscious Sedation Committee’s Quality Improvement tool in appendix 5) and entering it into the Institution’s sedation/analgesia data base developed by the Outcomes Management Department. The Outcomes Management Department will then synthesize all such data and forward it to the Performance Improvement Committee for review and analysis. Opportunities for improved patient care identified by such Performance Improvement Committee activities will result in
recommendations from that body to the Chief of Professional Services for his/her consideration and implementation. The Medical Center Conscious Sedation Committee stands available for
consultation as well as to assist in any corrective action in such matters if so requested by the Chief of Professional Services.
VII. REFERENCES AND RESOURCES
A. Practice Guidelines for Sedation and Analgesia by Non-Anesthesiologists. An updated report by the American Society of Anesthesiologists Task Force on Sedation and Analgesia by Non-Anesthesiologists. Anesthesiology 2002;96:1004-17.
B. Revisions to Anesthesia Care Standards. Comprehensive Accreditation Manual for Hospitals. Effective January 1, 2001. Joint Commission on Accreditation of Healthcare Organizations. Available at: http://www.jcaho.org/standard/aneshap.html. Accessed: January 24, 2002.
C. American Society of Anesthesiologists: Continuum of Depth of Sedation—Definition of General Anesthesia and Levels of Sedation/Analgesia. Available at http://www.asahq.org/Standards/20. htm. Accessed on: February 6, 2002.
D. Kelly JS. Sedation by non-anesthesia personnel provokes safety concerns; anesthesiologists must balance JCAHO standards, politics, & safety. APSF Newsletter 2001;16(3):44-46.
E. AHA Advanced Cardiac Life Support Provider Manual. Dallas: American Heart Association, 2001: 38, 77, 100, 112, 147, 160, 173.
F. Cardiac Dysrhythmia Protocols. In: Tarascon Pocket Pharmacopoeia 2002 Classic Shirt-Pocket Edition. Loma Linda, CA: Tarascon Publishing, 2002: 127.
G. Practice Guidelines for Preoperative Fasting and Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration: Application to Healthy Patients Undergoing Elective Procedures. American Society of Anesthesiologists Task Force on Preoperative Fasting. Anesthesiology 1999;90:896-905.
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H. Taketomo CK, Hodding JH, Kraus DM. Flumazenil. In: Pediatric Dosage Handbook, 6th ed. Lexi-Comp, Inc., Hudson (OH), 1999:392-4.
I. Kauffman RE, et al. Guidelines for monitoring and management of pediatric patients during and after sedation for diagnostic and therapeutic procedures. Pediatrics 1992;89:110-5.
J. Bailey PL, Pace NL, Ashburn MA, et al. Frequent hypoxemia and apnea after sedation with midazolam and fentanyl. Anesthesiology 1990;73:826-30.
Attachment: Appendix I Age-Specific Hourly Cumulative Dosages of Sedatives and Analgesics Appendix II Age-Specific Dosages of Naloxone and Flumazenil
Appendix III Adult Resuscitation Guidelines
Appendix IV Appropriate Preprocedure Fasting Guidelines
Appendix V Medical Center Conscious Sedation Committee Quality Improvement Tool Effective Date: 06-22-96 Revision Dates: 07-01-02 Reviewed Dates: 07-01-05
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APPENDIX I
AGE-SPECIFIC HOURLY CUMULATIVE DOSAGES OF SEDATIVES AND ANALGESICS Medication Age < 16 yrs. Ages 16 - 70 yrs. Age > 70 yrs.
choral hydrate PO > 75 mg/kg not recommended4 not recommended4 (2 gms. maximum)
pentobarbital PO > 5 mg/kg not recommended4 not recommended4 IM not recommended4
IV > 2 mg/kg
ketamine PO > 10 mg/kg not recommended4 not recommended4 IM > 2 mg/kg
IV >1 mg/kg6
midazolam3 PO > 0.5 mg/kg > 4 mg IV/IM > 2 mg IV/IM
IM > 0.2 mg/kg PO not recommended2,4 PO not recommended2,4 IV > 0.1 mg/kg
diazepam3 PO not recommended2,4 > 10 mg IV1 > 5 mg IV1
IM not recommended4 IM not recommended4 IM not recommended4
IV > 0.2 mg/kg PO not recommended2,4 PO not recommended2,4 lorazepam3 PO not recommended2,4 > 2 mg IV1 > 1 mg IV1
IM not recommended4 IM not recommended4 IM not recommended4 IV > 0.1 mg/kg PO not recommended2,4 PO not recommended2,4 morphine PO not recommended4 > 10 mg IV/IM1 > 5 mg IV/IM1
IM > 0.2 mg/kg PO not recommended4 PO not recommended4 IV > 0.15 mg/kg
meperidine PO not recommended4 > 100 mg IV/IM > 50 mg IV/IM IM > 2 mg/kg PO not recommended4 PO not recommended4 IV > 1.5 mg/kg
fentanyl > 3 ug/kg IV/IM > 100 ug IV/IM > 50 ug IV/IM
PO not recommended4 PO not recommended4 PO not recommended4 droperidol5 PO not recommended4 PO not recommended1,4 PO not recommended1,4
IM > 30 ug/kg > 5 mg IV/IM > 2.5 mg IV/IM IV > 30 ug/kg
