Download Facilitating EndotracheaL Intubation by Laryngoscopy

Principal Investigators: David R Janz, MD, MSc; Matthew W Semler, MD
Faculty Mentor: Todd W Rice, MD, MSc
Version Date: 12/18/13
Study Title: Facilitating EndotracheaL Intubation by Laryngoscopy technique and Apneic
Oxygenation Within the Intensive Care Unit (FELLOW)
Institution/Hospital: Vanderbilt University Medical Center
The FELLOW Study
Facilitating EndotracheaL Intubation by Laryngoscopy technique
and Apneic Oxygenation Within the Intensive Care Unit
Principal Investigators
David R Janz and Matthew W Semler
Department of Medicine
Division of Allergy, Pulmonary, and Critical Care Medicine
Vanderbilt University School of Medicine
Faculty Mentor
Todd W. Rice
Department of Medicine
Division of Allergy, Pulmonary, and Critical Care Medicine
Vanderbilt University School of Medicine
Principal Investigators: David R Janz, MD, MSc; Matthew W Semler, MD
Faculty Mentor: Todd W Rice, MD, MSc
Version Date: 12/18/13
Study Title: Facilitating EndotracheaL Intubation by Laryngoscopy technique and Apneic
Oxygenation Within the Intensive Care Unit (FELLOW)
Institution/Hospital: Vanderbilt University Medical Center
Table of Contents:
Study Schema
1.0
Background and Rationale
2.0
Hypotheses and Specific Aims
3.0
Inclusion/Exclusion Criteria
4.0
Consent
5.0
Enrollment/Randomization
6.0
Study Procedures
7.0
Safety Measures / Adverse Event Reporting
8.0
Study Withdrawal/Discontinuation
9.0
Statistical Considerations
10.0 Privacy/Confidentiality Issues
11.0 Follow-up and Record Retention
Appendices
Principal Investigators: David R Janz, MD, MSc; Matthew W Semler, MD
Faculty Mentor: Todd W Rice, MD, MSc
Version Date: 12/18/13
Study Title: Facilitating EndotracheaL Intubation by Laryngoscopy technique and Apneic
Oxygenation Within the Intensive Care Unit (FELLOW)
Institution/Hospital: Vanderbilt University Medical Center
Background and Rationale
Respiratory failure requiring endotracheal intubation occurs in as many as 40% of
critically ill patients (1). Procedural complications including failed attempts at
intubation, esophageal intubation, arterial oxygen desaturation, aspiration, hypotension,
cardiac arrest, and death are common in this setting (2-4). While there are many
important components of successful airway management in critical illness, the
maintenance of adequate arterial hemoglobin saturation from procedure initiation until
endotracheal tube placement is paramount as desaturation is the most common factor
associated with peri-intubation cardiac arrest and death (5). Interventions that either
shorten the duration of time required for tube placement or prolong the period before
desaturation may be effective in improving outcome. The high rate of complications and
the lack of existing evidence regarding the efficacy of current airway management
techniques in shortening the time to airway establishment or prolonging the time to
desaturation mandates further investigation.
Laryngoscopy Technique in Emergent Endotracheal Intubation of the Critically Ill.
In an effort to reduce procedure-related complications, new video laryngoscopy
devices have been developed that allow improved visualization of the glottis compared to
direct laryngoscopy with a straight or curved blade (6, 7). The improvement in glottic
visualization with video laryngoscopy devices may result in decreased time and
complications associated with endotracheal intubation; however the current literature
supporting this theoretical benefit is conflicting. Repeated studies have demonstrated
improved glottic visualization, improved success with first attempt, and decreased
esophageal intubation with video laryngoscopy (4, 8). Unfortunately, the existing
literature comparing video and direct laryngoscopy suffers from flaws in study design
including reliance on observational data, poor controlling within randomized trials, and
use of operators of wide-ranging expertise outside of the ICU setting. This lack of
definitive data in a critically ill population with non-expert operators, combined with
increased time to intubation and mortality in certain patient populations when using video
laryngoscopy (9) and the cost of providing video laryngoscopy equipment suggest that
further study is needed before this technique can be considered superior to direct
laryngoscopy for routine intubation of critically ill patients.
Critically ill patients in the medical ICU frequently require airway management
(1) and often have little physiologic reserve to tolerate peri-intubation complications.
Pulmonary and Critical Care Medicine (PCCM) fellows in training, by nature of their
sheer proximity to these patients and as a part of their curriculum, are often called upon
to perform emergent endotracheal intubation. Although video laryngoscopy has been
studied extensively in other patient and operator populations, there is a dearth of literature
guiding us in the optimal emergent intubation technique of the critically ill by PCCM
fellows in training. One recent, retrospective cohort study (4) attempted to address this
lack of data by instituting a policy change from direct laryngoscopy by PCCM fellows to
only video laryngoscopy and collecting outcomes related to intubation. Using past direct
Principal Investigators: David R Janz, MD, MSc; Matthew W Semler, MD
Faculty Mentor: Todd W Rice, MD, MSc
Version Date: 12/18/13
Study Title: Facilitating EndotracheaL Intubation by Laryngoscopy technique and Apneic
Oxygenation Within the Intensive Care Unit (FELLOW)
Institution/Hospital: Vanderbilt University Medical Center
laryngoscopy as a historical control group, the use of video laryngoscopy was associated
with improved first attempt success rate and fewer esophageal intubations. Although
these are promising results and a homogenous operator population was used, the
observational study design and use of historical controls introduce sufficient bias to
prevent definitive conclusion from being drawn.
In order to answer the question of whether the routine use of video laryngoscopy
as opposed to direct laryngoscopy by non-expert operators in the intensive care unit
would decrease the rate of failed first airway attempts, a randomized clinical trial using
operators of similar expertise is needed.
Apneic Oxygenation in Emergent Endotracheal Intubation of the Critically Ill.
Maintaining adequate hemoglobin saturation is a critical component of airway
management. In urgent intubations outside the operating room, desaturation is frequent
and is the most common factor associated with cardiac arrest and death (5). The
traditional approach to avoiding peri-intubation hypoxemia in critically ill patients has
focused on maximizing preoxygenation to extend the period of apnea without
desaturation during which rapid sequence intubation can be performed. By replacing
alveolar nitrogen with oxygen, preoxygenation attempts to maximize the total oxygen
reservoir available during apnea. In patients with a normal functional residual capacity,
adequate ventilation perfusion matching, and low metabolic demands, adequate
preoxygenation can extend the duration of apnea without desaturation to as long as 8-10
minutes. However in critically ill patients with diminished functional residual capacity,
poor ventilation perfusion matching, and elevated peripheral oxygen consumption,
preoxygenation is less effective (10) and often insufficient to prevent desaturation during
even short periods of apnea (11).
The shortcomings of preoxygenation alone in ensuring patient safety during
urgent airway management have generated interest in the feasibility and efficacy of
continued oxygen delivery during the apneic period. During paralysis when there is no
diaphragmatic movement or lung expansion, oxygen continues to move from the alveoli
into the bloodstream and out to the peripheral tissues where it is consumed to generate
carbon dioxide. Because of the affinity of carbon dioxide for hemoglobin and it’s
buffering in the blood stream, a smaller volume of carbon dioxide returns to the alveoli
than the volume of oxygen extracted. This results in a subatmospheric pressure in the
alveoli driving the flow of gas from the pharynx into the lungs. By providing a continued
source of oxygen to the pharynx during apnea, alveolar oxygenation and consequently
hemoglobin saturation can be maintained (12). While this technique of ‘apneic
oxygenation’ has been employed for more than half a century during brain death
examination and more recently during bronchoscopy, colonoscopy, and otolaryngeal
procedures, utilization during airway management has been limited. Teller et al (13)
studied 12 patients with ASA grade 1-2 requiring general anesthesia for elective surgery
in a cross-over study examining preoxygenation technique and apneic oxygenation with
10 minutes of apnea and desaturation defined by SpO2<92%. In the control group mean
desaturation occurred at 6.8 minutes whereas in the apneic oxygenation group all patients
Principal Investigators: David R Janz, MD, MSc; Matthew W Semler, MD
Faculty Mentor: Todd W Rice, MD, MSc
Version Date: 12/18/13
Study Title: Facilitating EndotracheaL Intubation by Laryngoscopy technique and Apneic
Oxygenation Within the Intensive Care Unit (FELLOW)
Institution/Hospital: Vanderbilt University Medical Center
maintained SpO2 above 92% for 10 minutes. Taha et al (14) randomized 30 healthy
patients undergoing elective surgery with general anesthesia to receive 5 L/min oxygen
by insufflation into the nasopharynx during apnea or no insufflation of oxygen.
Participants were monitored until saturation on pulse oximetry fell below 95% or until 6
minutes of apnea had elapsed. The mean duration of apnea before desaturation below
95% in the control group was 3.65 minutes and in the intervention arm no patient
desaturated below 100% during the 6 minutes of apnea. Baraka et al (15) randomized 34
patients undergoing elective general anesthesia for a gastric band to oxygen insufflation
into the nasopharynx versus control with regard to desaturation below 95%. All patients
in the control group desaturated to less than 95% SpO2 within four minutes with a mean
time of 145 seconds and no patient in the treatment arm desaturated within the fourminute apnea window. Ramachandran et al (16) randomized 30 obese men undergoing
general anesthesia for elective surgery to receive 5L/min of oxygen by nasal prongs or no
oxygen by nasal prongs. After neuromuscular blockade, a laryngoscope was held in the
airway to simulate a Lehane grade 4 view until the SpO2 decreased to 95% or 6 minutes
of apnea had elapsed at which point tracheal intubation was performed. The duration of
apnea before desaturation to 95% was around 3.5 min in the control compared to 5.29
minutes in the intervention and the lowest SpO2 was 88% vs. 94% respectively. Despite
the small size of these studies, all showed a signal in favor of apneic oxygenation without
any evidence of increase risk and cumulatively they suggest that in patients undergoing
elective intubation in the operating room, apneic oxygenation by nasal administration
may safely prolong the duration of apnea without desaturation by at least 1-2 minutes.
There are only two ongoing registered trials of apneic oxygenation, one of which
(NCT01886807) aims to evaluate the technique during intubation of pediatric patients
undergoing elective surgery and one of which (NCT00782977) is evaluating the effect of
the technique on arterial blood oxygenation in healthy adults undergoing general
anesthesia for elective surgery.
Despite the lack of robust clinical evidence, the physiologic rationale for apneic
oxygenation and the perceived lack of risks have led airway management experts to
advocate the empiric use of the technique during urgent airway management outside of
the operating room. Weingart and Levitan have recommended a technique by which a
nasal cannula delivering 15L/min of oxygen is left in place for the duration of
laryngoscopy and intubation in order to provide oxygen to the nasopharynx for mass flow
to the lungs without obstructing the operators access to the oral opening (17). Inadequate
evidence of benefit in the setting of urgent airway management coupled with concerns
about added setup time, cost, and potential minor risks including reduced mask fit have
led to heterogeneous adoption of apneic oxygenation into clinical practice.
In order to resolve these questions of efficacy and safety, a prospective,
randomized clinical trial of apneic oxygenation during urgent airway management
outside of the operating room is needed.
Principal Investigators: David R Janz, MD, MSc; Matthew W Semler, MD
Faculty Mentor: Todd W Rice, MD, MSc
Version Date: 12/18/13
Study Title: Facilitating EndotracheaL Intubation by Laryngoscopy technique and Apneic
Oxygenation Within the Intensive Care Unit (FELLOW)
Institution/Hospital: Vanderbilt University Medical Center
Hypotheses
Laryngoscopy Technique: The primary hypothesis is that video laryngoscopy
will be superior to direct laryngoscopy in successful first attempt at endotracheal
intubation (defined by confirmed placement of an endotracheal tube in the trachea during
first laryngoscopy attempt) after controlling for the operator’s past number of procedures
with the equipment used.
Apneic Oxygenation: The primary hypothesis is that the provision of apneic
oxygenation during the endotracheal intubation procedure (defined as a nasal cannula
with 15 liters per minute of oxygen flow placed prior to sedation or neuromuscular
blockade and maintained until after completion of the procedure) will result in a higher
arterial oxygen saturation nadir (defined as lowest noninvasive oxygenation saturation
value observed between the administration of sedation and/or neuromuscular blockade
and 2 minutes after successfully secured airway or death) compared to no apneic
oxygenation.
Specific Aims
Laryngoscopy Technique: To conduct a randomized trial of direct versus video
laryngoscopy by PCCM fellows in patients admitted to the Medical ICU for
successful, first attempt endotracheal intubation accounting for the experience of
the operator at the time of the procedure with the specific intubating equipment.
We will also collect data on lowest procedural arterial oxygen saturation, number
of attempts, need for second operator, need for additional intubating equipment,
esophageal intubations, procedural hypotension, airway trauma, and in-hospital
mortality.
Apneic Oxygenation: To conduct a randomized trial of apneic oxygenation
during endotracheal intubation compared to no apneic oxygenation for lowest
measured arterial oxygen saturation during the procedure.
Inclusion/Exclusion Criteria
We will include airway management events in which the planned operator is a
PCCM fellow at any stage of training; the patient is admitted to the Medical ICU; and the
administration of sedation and/or neuromuscular blockade is planned. We will exclude
airway management events in which the operator is not a PCCM fellow (including thos
performed by housestaff, PCCM attendings, and anesthesiologists) or the operator feels
that specific intubating equipment or oxygenation technique will be required.
Consent
As direct laryngoscopy, video laryngoscopy, apneic oxygenation during
intubation, and intubation without the administration of oxygen are all commonly used
techniques in the current practice of endotracheal intubation of critically ill patients in the
medical ICU by PCCM fellows, a waiver of consent will be requested from the IRB.
Principal Investigators: David R Janz, MD, MSc; Matthew W Semler, MD
Faculty Mentor: Todd W Rice, MD, MSc
Version Date: 12/18/13
Study Title: Facilitating EndotracheaL Intubation by Laryngoscopy technique and Apneic
Oxygenation Within the Intensive Care Unit (FELLOW)
Institution/Hospital: Vanderbilt University Medical Center
Enrollment/Randomization
Our target population will be patients admitted to the Medical ICU at Vanderbilt
University Medical Center undergoing endotracheal intubation by PCCM fellows.
Inclusion and exclusion will be strictly determined by our inclusion and exclusion
criteria. Opaque randomization envelopes will be present in the medical ICU and
available to PCCM fellows when it is determined endotracheal intubation will be
performed. Randomization will occur in permuted blocks of four to eight and the study
personnel along with the operators will be blinded to the randomization assignments prior
to the opening of an envelope. Once it has been determined by the treating team that (1)
intubation is required, (2) the PCCM fellow will be the first to attempt the procedure, and
(3) a specific intubating device or oxygenation strategy is not indicated, the operator will
open the envelope and follow the factorialized assignment of either direct or video
laryngoscopy and either nasal cannula oxygen delivery during the entire procedure or no
provision of a nasal cannula.
Study Procedures
Study Design
This study will be structured as an un-blinded, factorialized, randomized
controlled trial of (1) Video Laryngoscopy (McGrath® video laryngoscope,
GlideScope® video laryngoscope, or bronchoscope) vs. Direct Laryngoscopy and (2)
Apneic Oxygenation vs. no Apneic Oxygenation in intubations of patients in the medical
ICU by PCCM fellows.
Data Collection
Once the operator has received their factorialized assignment, the operator will
obtain the assigned laryngoscopy device, work with respiratory therapy to institute the
administration of 15L of oxygen by nasal cannula, and then proceed with the airway
management procedure as planned.
A data collection sheet will be included with the randomization sheet. The data
collection sheet will be divided into two components. The first component will solicit
information used for determination of primary outcomes of the study (laryngoscopy
device used, nasal cannula oxygen in place throughout intubation, successful placement
of an endotracheal tube in the trachea on first attempt, other devices used on first
attempt, highest and lowest arterial oxygen saturation prior to and during the procedure)
and will be filled out and signed by a member of the ICU staff present at the procedure
but not involved in the performance of the procedure or the study (eg. Charge nurse,
bedside nurse, respiratory therapist). The second component will solicit more detailed
information regarding the events of the procedure and the experience of the operator with
the specific equipment employed (procedural medications used, number of laryngoscopy
attempts before successful intubation, need for additional intubating equipment beyond
direct or video laryngoscopy and type of equipment, need for additional operator,
Principal Investigators: David R Janz, MD, MSc; Matthew W Semler, MD
Faculty Mentor: Todd W Rice, MD, MSc
Version Date: 12/18/13
Study Title: Facilitating EndotracheaL Intubation by Laryngoscopy technique and Apneic
Oxygenation Within the Intensive Care Unit (FELLOW)
Institution/Hospital: Vanderbilt University Medical Center
aspiration, esophageal intubation, Cormack-Lehane grading of glottic view achieved on
first intubation attempt, estimated time from beginning of laryngoscopy to successful
intubation, hypotension or cardiac arrest during the procedure, airway trauma, periprocedural mortality, and the estimated number of times the operator has used the
assigned intubating equipment prior to the current procedure) and will be completed by
the PCCM fellow after the conclusion of the procedure.
Collected data will then be transferred to the study personnel and de-identified
data will be entered into a REDCap database. Additional de-identified data will be
collected from the electronic medical record and stored in the REDCap database and will
include, but not be limited to: age, sex, weight, height, date of ICU admission, diagnoses
on ICU admission, APACHE II score, condition requiring intubation, ventilator-free
days, ICU-free days, and hospital mortality.
Outcome Measures
Laryngoscopy Technique: The primary outcome for the laryngoscopy technique
arm will be incidence of successful first attempt at airway management. Secondary
outcomes will include lowest procedural arterial oxygen saturation, number of attempts,
need for second operator, need for additional intubating equipment, esophageal
intubations, airway trauma, procedural hypotension, and in-hospital mortality.
Apneic Oxygenation: The primary outcome for the apneic oxygenation arm will
be lowest oxygenation saturation between initiation of sedation and/or neuromuscular
blockade and 2 minutes after completion of the procedure. Secondary outcomes will
include lowest procedural arterial oxygen saturation accounting for saturation at the time
of initiation of sedation and/or neuromuscular blockade, number of attempts, need for
second operator, need for additional intubating equipment, esophageal intubations,
airway trauma, procedural hypotension, and in-hospital mortality.
Safety Measures/Adverse Event Reporting
Serious and unexpected adverse events associated with the procedure will be
recorded and reported to the IRB. As endotracheal intubation in the critical care setting is
known to be independently associated with numerous adverse events including failed
attempts at intubation, esophageal intubation, arterial oxygen desaturation, aspiration,
hypotension, cardiac arrest, and death these events will be continuously monitored by
study personnel with intermittent statistical analysis to determine if a preponderance of
adverse events in one study group merits stoppage of the trial. However, in the absence
of an imbalance of the above events between study groups, these events are expected in
the routine performance of the airway management procedure and will not be
individually reported to the IRB as unexpected adverse events.
As an additional safety measure, the exclusion criteria specifically state that
airway management events in which the operator foresees the potential need for specific
equipment or oxygenation technique will not be included in the trial so all airway
management events studied will be those in which the treating clinical felt equipoise
between the procedural techniques being examined. Further, only the conditions at
initiation of the airway management event are proscribed by the study protocol and if at
Principal Investigators: David R Janz, MD, MSc; Matthew W Semler, MD
Faculty Mentor: Todd W Rice, MD, MSc
Version Date: 12/18/13
Study Title: Facilitating EndotracheaL Intubation by Laryngoscopy technique and Apneic
Oxygenation Within the Intensive Care Unit (FELLOW)
Institution/Hospital: Vanderbilt University Medical Center
any time during the procedure the operator chooses to employ an alternative airway
management strategy they are free to do so.
Statistical Considerations
Data will be analyzed with Fisher exact test for categorical variables, Student’s Ttests for normally distributed data, and Mann-Whitney U Tests for non-normally
distributed data. As previous observational analyses have shown that the success rate of
PCCM fellows at direct laryngoscopy is 68% compared to 91% with video laryngoscopy,
we will need to randomize 142 airway management events to detect a significant
difference in rate of successful first attempt intubation with 90% power. Anticipating a
small number of cases in which the primary endpoints may be unavailable due to the
emergent circumstances surrounding the procedure, we will prospectively plan to
continue the study until a total of 150 airway management events have been included.
Privacy/Confidentiality Issues
The PIs and study personnel will be directly responsible for the collection of all
data. Clinical data regarding each airway management event will be collected and seen
only by the PIs, their faculty mentor, and study personnel and will include but not be
limited to age, sex, weight, height, date of ICU admission, diagnoses on ICU admission,
APACHE II score, condition requiring intubation, ventilator-free days, ICU-free days,
and hospital mortality. Once this clinical data has been collected from medical record, all
identifiers (medical record number, name, date of birth) will be removed from the clinical
data. All data will be stored electronically in a secure, REDCap database that will only
be available to the PIs and study peronnel.
Follow-Up
After completion of an on-study airway management event, monitoring of the
electronic medical record will continue until completion of hospitalization in order to
obtain relevant clinical outcomes.
Record Retention
Protected health information will be collected after an airway management event
until the time of hospital discharge or death. Study records will be stored in the secure,
REDCap database for five years, at which time the PIs and their faculty mentor will
reassess the need to continue to maintain the database or if the data can be deleted.
Principal Investigators: David R Janz, MD, MSc; Matthew W Semler, MD
Faculty Mentor: Todd W Rice, MD, MSc
Version Date: 12/18/13
Study Title: Facilitating EndotracheaL Intubation by Laryngoscopy technique and Apneic
Oxygenation Within the Intensive Care Unit (FELLOW)
Institution/Hospital: Vanderbilt University Medical Center
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Principal Investigators: David R Janz, MD, MSc; Matthew W Semler, MD
Faculty Mentor: Todd W Rice, MD, MSc
Version Date: 12/18/13
Study Title: Facilitating EndotracheaL Intubation by Laryngoscopy technique and Apneic
Oxygenation Within the Intensive Care Unit (FELLOW)
Institution/Hospital: Vanderbilt University Medical Center
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