Semler Et Al 2016
Semler Et Al 2016
Semler Et Al 2016
ORIGINAL ARTICLE
Hypoxemia is the most common death (5). The traditional approach to abnormalities render preoxygenation less
complication of endotracheal intubation in avoiding desaturation during intubation is effective (7) and often insufcient to
the critically ill (14) and the strongest risk preoxygenation (610). However, in prevent desaturation during even short
factor for periprocedural cardiac arrest and critically ill patients, acute physiologic periods of apnea (11).
( Received in original form September 6, 2015; accepted in final form September 30, 2015 )
Supported by NHLBI T32 award (HL087738 09). Data collection used the Research Electronic Data Capture (REDCap) tool developed and maintained with
Vanderbilt Institute for Clinical and Translational Research grant support (UL1 TR000445 from National Center for Advancing Translational Sciences/National
Institutes of Health). The funding institutions had no role in conception, design, or conduct of the study; collection, management, analysis, interpretation, or
presentation of the data; or preparation, review, or approval of the manuscript.
Authors Contributions: Study concept and design, M.W.S., D.R.J., and T.W.R. Acquisition of data, M.W.S., D.R.J., R.J.L., D.T.M., B.C.N., T.R.A., R.D.K.,
B.A.F., M.J.N., A.C.M., E.G.K., M.A.W., and L.E.H. Analysis and interpretation of data, M.W.S., D.R.J., R.J.L., D.T.M., B.C.N., T.R.A., R.D.K., B.A.F., M.J.N.,
A.C.M., E.G.K., M.A.W., and L.E.H. Drafting of the manuscript, M.W.S., D.R.J., and T.W.R. Critical revision of the manuscript for important intellectual content,
D.R.J., R.J.L., D.T.M., B.C.N., T.R.A., R.D.K., B.A.F., M.J.N., A.C.M., E.G.K., M.A.W., and L.E.H. Statistical analysis, M.W.S, D.R.J., and T.W.R. Study
supervision, M.W.S., D.R.J., R.J.L., and T.W.R. M.W.S. and D.R.J. had full access to all the data in the study and take responsibility for the integrity of the data
and the accuracy of the data analysis. M.W.S. and D.R.J. conducted and are responsible for the data analysis.
Correspondence and requests for reprints should be addressed to Matthew W. Semler, M.D., 1161 21st Avenue South, T-2220 MCN, Nashville, TN 37232-
2650. E-mail: [email protected]
This article has an online supplement, which is accessible from this issues table of contents at www.atsjournals.org
Am J Respir Crit Care Med Vol 193, Iss 3, pp 273280, Feb 1, 2016
Copyright 2016 by the American Thoracic Society
Originally Published in Press as DOI: 10.1164/rccm.201507-1294OC on October 1, 2015
Internet address: www.atsjournals.org
Semler, Janz, Lentz, et al.: Apneic Oxygenation for Emergent Intubation 273
ORIGINAL ARTICLE
274 American Journal of Respiratory and Critical Care Medicine Volume 193 Number 3 | February 1 2016
ORIGINAL ARTICLE
46 were excluded
23 required intubation too urgently to obtain envelope
13 for cardiac arrest
8 for respiratory arrest
2 for acute hypoxic respiratory failure
18 were felt to require video or fiberoptic intubation
1 was felt to require direct laryngoscopy
1 was felt to require apneic oxygenation
3 were excluded for unknown reasons
Figure 1. Enrollment, randomization, intervention, and analysis. Of 196 adults intubated by pulmonary and critical care medicine fellows during the study
period, 46 were excluded and 150 were randomized, followed, and included in the intention-to-treat analysis.
convenience sample of around 10% of study additional airway equipment or operators, We performed four prespecied
intubations. and incidence of nonhypoxemia secondary analyses: (1) the effect of the
Subjective assessments of Cormack- complications. Tertiary outcomes included intervention on secondary and tertiary
Lehane grade of view (24), difculty of duration of mechanical ventilation, ICU outcomes, (2) the effect of the intervention
intubation, and airway complications length of stay, and in-hospital mortality. on the primary outcome in prespecied
during the procedure were self-reported by patient and procedural subgroups,
the operator. All other data on baseline Statistical Analysis (3) per-protocol analyses comparing
characteristics, prelaryngoscopy and Anticipating a SD of 10% in lowest lowest arterial oxygen saturation between
postlaryngoscopy management, and arterial oxygen saturation (6), enrollment of patients who received apneic oxygenation
clinical outcomes were collected from the 150 patients would provide 80% statistical with those who did not, and (4) linear
medical record by study personnel. All power (at a two-sided a level of 0.05) to regression for the outcome of lowest arterial
patients were followed until the rst of detect a difference between groups in oxygen saturation in which the exposure
hospital discharge, death, or 28 days after mean lowest arterial oxygen saturation of variable of randomized group assignment
enrollment. 4.6%, within the 5% minimum difference was accompanied rst by just the covariate
considered clinically meaningful in prior of oxygen saturation at induction and
Study Outcomes studies (see online supplement) (6, 9, 17, then by potential baseline confounders.
The primary outcome was the lowest 18, 22). Subgroup analyses were performed
arterial oxygen saturation measured by Analyses were conducted according using logistic regression with heterogeneity
continuous pulse oximetry (SpO2) between to a statistical analysis plan that was of treatment effect determined on the
induction and 2 minutes after successful publically available before completion of basis of statistical test for interaction
endotracheal tube placement (lowest enrollment. Continuous variables were between treatment assignment and
arterial oxygen saturation). Secondary reported as mean 6 SD or median and subgrouping variable. A two-sided P value
efcacy outcomes included incidence of interquartile range (IQR); categorical less than 0.05 was used to determine
hypoxemia (SpO2 ,90%), severe hypoxemia variables as frequencies and proportions. signicance. All analyses were performed
(SpO2 ,80%), desaturation (decrease in Between-group differences were using SPSS Statistics v.22 (IBM Corp.,
SpO2 .3%), and change in saturation analyzed with the Mann-Whitney rank Armonk, NY) or R version 3.2.0 (R
from baseline. Secondary safety outcomes sum test for continuous variables, Fisher Foundation for Statistical Computing,
included Cormack-Lehane grade of glottic exact test for categorical variables, and Vienna, Austria).
view (24), incidence of successful Spearman rank correlation coefcient for
intubation on the rst laryngoscopy correlation between two continuous
attempt (placement of an endotracheal tube variables. The primary analysis was an Results
in the trachea during the rst insertion of unadjusted, intention-to-treat comparison
the laryngoscope into the oral cavity of patients randomized to apneic Enrollment and Baseline
without the use of any other devices), oxygenation versus usual care with regard Characteristics
number of laryngoscopy attempts, time to the primary outcome of lowest arterial Of 196 medical ICU patients intubated
from induction to intubation, need for oxygen saturation. by fellows during the study period,
Semler, Janz, Lentz, et al.: Apneic Oxygenation for Emergent Intubation 275
ORIGINAL ARTICLE
Patient characteristics
Age, median (IQR), yr 60 (5067) 60 (5168)
Male, n (%) 46 (63.0) 45 (58.4)
White, n (%) 62 (84.9) 63 (82.9)
BMI, median (IQR), kg/m2 28.6 (23.432.8) 28.6 (23.332.8)
APACHE II score, median (IQR) 22 (1727) 22 (1627)
Vasopressors, n (%) 9 (12.3) 11 (14.3)
Lowest MAP in prior 6 h, median (IQR), mm Hg 68 (5780) 65 (5779)
Lowest oxygen saturation in prior 6 h, median (IQR), % 91 (8893) 92 (8895)
Highest FIO2 in prior 6 h, median (IQR) 0.40 (0.300.80) 0.40 (0.270.60)
BiPAP use in prior 6 h, n (%) 31 (42.5) 26 (33.5)
Reintubation within 24 h of extubation, n (%) 11 (15.1) 9 (11.7)
Intensive care unit diagnoses, n (%)
Sepsis 50 (68.5) 49 (63.6)
Septic shock 14 (19.2) 20 (26.0)
Hemorrhagic shock 3 (4.1) 6 (7.8)
Cardiogenic shock 1 (1.4) 2 (2.6)
Myocardial infarction 9 (12.3) 4 (5.2)
COPD exacerbation 8 (11.0) 4 (5.2)
Hepatic encephalopathy 10 (13.7) 10 (13.0)
Delirium 35 (50.0) 33 (43.4)
Indication for intubation, n (%)
Hypoxic or hypercarbic respiratory failure 42 (57.5) 43 (55.8)
Altered mental status or encephalopathy 18 (24.7) 21 (27.3)
Other 13 (17.8) 13 (16.8)
Comorbidities complicating intubation, n (%)
BMI .30 kg/m2 23 (31.5) 25 (32.5)
Upper gastrointestinal bleeding 7 (9.6) 6 (7.8)
Limited mouth opening* 3 (4.1) 3 (3.9)
Limited neck mobility* 3 (4.1) 2 (2.6)
Head or neck radiation 1 (1.4) 0 (0.0)
Airway mass or infection 0 (0.0) 1 (1.3)
Witnessed aspiration 1 (1.4) 0 (0.0)
Epistaxis or oral bleeding 0 (0.0) 0 (0.0)
Preoxygenation, n (%)
Nonrebreather mask 32 (43.8) 25 (32.5)
BiPAP 23 (31.5) 23 (29.9)
Bag-valve-mask ventilation 31 (42.5) 33 (42.9)
Standard nasal cannulax 2 (2.7) 6 (7.8)
Other 1 (1.4) 0 (0.0)
Oxygen saturation at induction, median (IQR), % 98 (9499) 99 (96100)
Operator characteristics
Total number of prior intubations, median (IQR) 56 (4069) 68 (5269)
Months of fellowship training, median (IQR) 21.5 (14.429.5) 22.9 (15.431.6)
Definition of abbreviations: APACHE II = Acute Physiology and Chronic Health Evaluation II, ranging from 0 to 71 with higher scores indicating higher
severity of illness; BiPAP = bilevel positive airway pressure; BMI = body mass index; COPD = chronic obstructive pulmonary disease; IQR = interquartile
range; MAP = mean arterial pressure; shock = MAP less than 65 mm Hg or vasopressor use.
Noninvasively measured oxygen saturation at the time of induction was higher in the apneic oxygenation arm (P = 0.03).
*As reported by the fellow performing the intubation.
Bag-valve-mask ventilation was routinely accompanied by use of a positive end-expiratory pressure valve set to 510 cm H2O.
x
Standard nasal cannula delivered ,6 L/min of nonhumidified oxygen.
150 met no exclusion criteria and no differences in method of time of induction was 99% (IQR,
were enrolled (Figure 1). Patients preoxygenation (Table 1), choice of 96100%) with apneic oxygenation
randomized to receive apneic induction agent or neuromuscular compared with 98% (IQR, 9499%) with
oxygenation (n = 77) and usual care blocker, ventilation between induction usual care (P = 0.03).
(n = 73) were similar at baseline (Table 1). and laryngoscopy, or laryngoscope type,
There was no difference between the except for higher propofol use for Airway Management
two arms in the prior airway management induction in the usual care arm (13.7 vs. Five patients (6.8%) in the usual care arm
experience of the fellow performing 2.5%; P = 0.02) (see Table E1 in the online received apneic oxygenation during
the intubation (Table 1). There were supplement). Oxygen saturation at the intubation, and two patients (2.6%) in the
276 American Journal of Respiratory and Critical Care Medicine Volume 193 Number 3 | February 1 2016
ORIGINAL ARTICLE
Oxygenation outcomes
Lowest oxygen saturation, median (IQR), % 90 (8096) 92 (8499) 0.16
Lowest oxygen saturation ,90%, n (%) 34 (47.2) 34 (44.7) 0.87
Lowest oxygen saturation ,80%,* n (%) 18 (25.0) 12 (15.8) 0.22
Decrease in oxygen saturation, median (IQR), % 4.5 (114) 4.0 (012) 0.60
Decrease in oxygen saturation .3%, n (%) 40 (55.6) 41 (53.9) 0.87
Procedural outcomes
Intubation on the rst laryngoscopy attempt, n (%) 49 (67.1) 52 (67.5) 0.96
Number of laryngoscopy attempts, median (IQR) 1 (12) 1 (11) 0.60
Time from induction to secured airway, median (IQR), s 150 (102245) 132 (88205) 0.31
Clinical outcomes
Duration of mechanical ventilation, median (IQR), d 3 (27) 3 (110) 0.73
Intensive care unit length of stay, median (IQR), d 7 (310) 4 (29) 0.24
Died within 1 h of intubation, n (%) 1 (2.8) 0 (0.0) .0.99
Died before hospital discharge, n (%) 36 (49.3) 27 (35.1) 0.10
apneic oxygenation arm did not oxygen in the prior 6 hours, laryngoscope In an a priori dened per-protocol
(Figure 1). There was no difference choice, and operator experience, apneic analysis comparing patients who received
between those randomized to oxygenation did not impact the lowest apneic oxygenation (n = 80) with those
apneic oxygenation and usual care in arterial oxygen saturation during the who did not (n = 68), there was no
the rate of successful intubation on the procedure (see Table E3). difference in lowest arterial oxygen
rst laryngoscopy attempt (67.5 vs. saturation (92% [IQR, 8498%] vs. 90%
67.1%; P = 0.96), time from induction Secondary Analyses [IQR, 8096%], respectively; P = 0.21) or
to secured airway (132 vs. 150 s; P = 0.31), There was no difference in lowest arterial in any other clinical outcome (see Tables
or any other recorded aspect of the oxygen saturation between apneic E4 and E5 and Figure E3).
performance of the procedure (Table 2; see oxygenation and usual care in any of The values for lowest arterial
Table E2). the subgroups examined (Figure 3). oxygen saturation recorded concurrently
Specically, apneic oxygenation was not by independent observers and
Main Outcomes signicantly more effective for patients at the primary investigators were
There was no signicant difference potentially greater risk for hypoxemia strongly correlated (Spearmen R2 = 0.893;
between apneic oxygenation and usual based on higher FIO2 requirement, lower P , 0.001). Operators were frequently
care with regard to the primary outcome oxygen saturation at induction, lower compliant with general best-practices
of median lowest arterial oxygen ratio of oxygen saturation to FIO2 (SpO2/FIO2 in airway management including
saturation during the procedure: 92% (IQR, ratio [25]) in the prior 6 hours, higher body preoxygenation, equipment preparation,
8499%) versus 90% (IQR, 8096%), mass index, more difcult intubation, or end-tidal carbon dioxide detector
respectively (P = 0.16) (Figure 2). Apneic longer duration of laryngoscopy (see availability, and presence of a second
oxygenation did not impact the proportion Figure E1). The type of laryngoscopy operator (see Table E6).
of patients who experienced an oxygen device assigned did not modify the effect
saturation less than 90%, less than 80%, or of apneic oxygenation on lowest arterial
a desaturation greater than 3% during the oxygen saturation (P value for the Discussion
procedure (Table 2). There were no interaction = 0.15) (see Figure E2).
differences in duration of mechanical One patient in each arm of the study This randomized trial comparing
ventilation, ICU length of stay, or was missing a value for lowest arterial apneic oxygenation with usual care during
in-hospital mortality (Table 2). oxygen saturation. In sensitivity analyses endotracheal intubation of critically ill
In multivariable linear regression imputing both values (by carrying adults found that apneic oxygenation did
adjusting for saturation at induction alone forward the saturation at induction or by not increase the lowest arterial oxygen
or with age, body mass index, Acute assigning apneic oxygenation the highest saturation. There were no signicant
Physiology and Chronic Health Evaluation possible saturation and usual care the differences between apneic oxygenation and
II score, shock, prior noninvasive lowest), there remained no difference usual care in any primary or secondary
ventilation, highest fraction of inspired between apneic oxygenation and usual care. outcome, overall or in any subgroup.
Semler, Janz, Lentz, et al.: Apneic Oxygenation for Emergent Intubation 277
ORIGINAL ARTICLE
A Miguel-Montanes and coworkers (22) delivery in the control arm. Median lowest
100
observed higher oxygen saturation during arterial oxygen saturations for those
Lowest oxygen saturation (%)
intubation after their ICU switched from receiving 60 L/min apneic oxygenation
80
apneic oxygenation at 6 L/min to 60 L/min versus none were identical to our study at
and Wimalasena and coworkers (23) 92 and 90%, respectively.
reported a 6% decrease in the incidence Our study has several strengths. It is
60 of desaturation after their helicopter the rst randomized trial specically
emergency medical service adopted comparing apneic oxygenation with usual
apneic oxygenation at 15 L/min care during intubations outside the
40 by nasal cannula. operating room and is ve times larger than
P = .16 In contrast to prior studies, our trial any prior trial. The primary outcome, lowest
0 showed no difference between apneic arterial oxygen saturation during
Usual Care Apneic Oxygenation
oxygenation and usual care. There are intubation, is of interest to clinicians; has
B several potential explanations for this been used in prior airway management
100 100
discordance. Prior reports of apneic trials; and is linked to patient-centered
Oxygen saturation (%)
oxygenations use outside the operating outcomes, such as cardiac arrest and
80 80 room were before-after designs in which death. Collection of study endpoints
other changes over time may have by an independent observer and
confounded the perceived impact of apneic contemporaneous validation of these data
60 60
oxygenation. Self-reported outcomes in by the primary investigators reduces
prior studies may have predisposed to potential for observer bias. The limited
40 40 observer bias. In contrast to healthy exclusion criteria and relatively small
0 0
patients undergoing elective anesthesia number excluded promote generalizability.
Induction Lowest Induction Lowest (1619) and patients intubated primarily Our study also has limitations. Conduct
Figure 2. Lowest arterial oxygen saturation by for traumatic, hemodynamic, or neurologic in one medical ICU at a single academic
study group. (A) The primary outcome of lowest conditions (22, 23), most patients in our center may limit generalizability. High
arterial oxygen saturation between induction and study were intubated for respiratory failure. compliance with preoxygenation (including
2 minutes after completion of endotracheal For patients with pulmonary function so noninvasive ventilation for patients with
intubation (lowest oxygen saturation) is displayed abnormal that provision of oxygen by hypoxemia), patient positioning, and
for patients randomized to apneic oxygenation mask or noninvasive ventilation was equipment preparation best-practices may
(squares) and usual care (circles). Horizontal bars insufcient to avert intubation, providing have reduced the potential additive
represent median and interquartile range. (B) The 15 L/min by nasal cannula during impact of apneic oxygenation (6, 28, 29).
relationship between oxygen saturation at
intubation might be expected to be Had we used a standardized intubation
induction and lowest oxygen saturation is
displayed for each patient in the usual care (left)
similarly ineffective. Although our protocol (6) or a highly uniform group of
and apneic oxygenation (right) groups. analyses did not suggest efcacy for operators (7), we might have reduced
apneic oxygenation in any subgroup, practice-related variation in lowest arterial
whether apneic oxygenation could be oxygen saturation, making any effect of
Hypoxemia is the most common effective in patients with normal apneic oxygenation easier to detect.
complication of endotracheal intubation pulmonary function being intubated for Comparing apneic oxygenation with a nasal
(13) and the most closely linked to cardiac other reasons requires further study. cannula delivering ambient air (placebo)
arrest and death (5). Preoxygenation is Finally, whether the dose of apneic could have allowed blinding, but would
often insufcient to prevent desaturation oxygenation delivered was adequate have inaccurately represented usual care,
during intubation (3, 11) and the provision is important. Our use of 15 L/min via obscured complications related to
of supplemental oxygen during apnea has high-ow nasal cannula was based on the delivery of the intervention
been advocated as a safe and inexpensive expert recommendation (10) and is a (e.g., disruption of mask seal for
intervention to improve periintubation higher ow rate than prior trials in the bag-valve-mask ventilation by the nasal
oxygenation (10, 26, 27). The use of apneic operating room (1619) but lower than cannula itself), and created a safety
oxygenation has been reported in four the 60 L/min delivered in a recent hazard by providing a false source of
small randomized trials in the operating observational study (22). It seems unlikely oxygen to teams conducting emergent
room (1619) and two before-after that a higher ow rate would improve intubation. Our study was powered to
studies of emergent intubation (22, 23). results, however, based on the recent detect the 5% difference in lowest
Trials of apneic oxygenation during PREOXYFLOW trial (9). Although the arterial oxygen saturation that has been
elective anesthesia ranged in size from PREOXYFLOW trial focused on considered clinically meaningful in prior
12 to 34 patients, all without acute preoxygenation with high-ow nasal trials (6, 9, 17, 18), but a smaller difference
pulmonary dysfunction (1619). cannula versus face mask, saturation at might have been missed. Exclusion of
Provision of 35 L/min of oxygen induction was the same in both arms and patients clinically determined to require
nasally signicantly prolonged the the high-ow nasal cannula continued video laryngoscopy may limit applicability
duration of apnea without desaturation to deliver 60 L/min of oxygen during of our results to patients with abnormal
(1619). Outside the operating room, laryngoscopy compared with no oxygen upper airway anatomy at risk for prolonged
278 American Journal of Respiratory and Critical Care Medicine Volume 193 Number 3 | February 1 2016
ORIGINAL ARTICLE
10
prevent complications (e.g., effective
Mean Difference in
ba < 1 tion
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Figure 3. Subgroup analyses. The mean difference in lowest arterial oxygen saturation (%)
Author disclosures are available with the text
between apneic oxygenation and usual care is given for patients in prespecified subgroups of this article at www.atsjournals.org.
present at the time of induction (circles) and arising after procedure initiation (squares). Vertical
bars represent the 95% confidence interval around the mean difference. BMI = body mass index in
kg/m2; FIO2 in 6 hours prior = the highest fraction of inspired oxygen in the 6 hours before the Acknowledgment: The authors thank
intubation; time to intubation = time from induction until successful endotracheal intubation. the nurses, respiratory therapists, residents,
and attending physicians of the Vanderbilt
intubation times. Although not observed in The results of our trial suggest that, for Medical Intensive Care Unit for making this
our analyses, benet in specic subgroups patients being intubated in the medical ICU, study possible. Additionally, they appreciate
the critical review of the manuscript
of patients (e.g., severe hypoxic respiratory routine use of apneic oxygenation is safe but provided by Wesley H. Self, M.D.; James R.
failure, preserved pulmonary function) ineffective. Safety without efcacy is Sheller, M.D.; and Arthur P. Wheeler, M.D. at
cannot be excluded. insufcient in the high-stakes, time- Vanderbilt University Medical Center.
Semler, Janz, Lentz, et al.: Apneic Oxygenation for Emergent Intubation 279
ORIGINAL ARTICLE
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280 American Journal of Respiratory and Critical Care Medicine Volume 193 Number 3 | February 1 2016