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Randomized Controlled Trial
. 2018 Feb 27;319(8):779-787.
doi: 10.1001/jama.2018.0156.

Effect of Bag-Mask Ventilation vs Endotracheal Intubation During Cardiopulmonary Resuscitation on Neurological Outcome After Out-of-Hospital Cardiorespiratory Arrest: A Randomized Clinical Trial

Patricia Jabre  1 , Andrea Penaloza  2 , David Pinero  3 , Francois-Xavier Duchateau  4 , Stephen W Borron  5 , Francois Javaudin  6 , Olivier Richard  7 , Diane de Longueville  8 , Guillem Bouilleau  9 , Marie-Laure Devaud  10 , Matthieu Heidet  11 , Caroline Lejeune  12 , Sophie Fauroux  13 , Jean-Luc Greingor  14 , Alessandro Manara  15 , Jean-Christophe Hubert  16 , Bertrand Guihard  17 , Olivier Vermylen  18 , Pascale Lievens  19 , Yannick Auffret  20 , Celine Maisondieu  21 , Stephanie Huet  22 , Benoît Claessens  8 , Frederic Lapostolle  23 , Nicolas Javaud  24 , Paul-Georges Reuter  25 , Elinor Baker  23 , Eric Vicaut  26 , Frédéric Adnet  23
Affiliations
Randomized Controlled Trial

Effect of Bag-Mask Ventilation vs Endotracheal Intubation During Cardiopulmonary Resuscitation on Neurological Outcome After Out-of-Hospital Cardiorespiratory Arrest: A Randomized Clinical Trial

Patricia Jabre et al. JAMA. .

Abstract

Importance: Bag-mask ventilation (BMV) is a less complex technique than endotracheal intubation (ETI) for airway management during the advanced cardiac life support phase of cardiopulmonary resuscitation of patients with out-of-hospital cardiorespiratory arrest. It has been reported as superior in terms of survival.

Objectives: To assess noninferiority of BMV vs ETI for advanced airway management with regard to survival with favorable neurological function at day 28.

Design, settings, and participants: Multicenter randomized clinical trial comparing BMV with ETI in 2043 patients with out-of-hospital cardiorespiratory arrest in France and Belgium. Enrollment occurred from March 9, 2015, to January 2, 2017, and follow-up ended January 26, 2017.

Intervention: Participants were randomized to initial airway management with BMV (n = 1020) or ETI (n = 1023).

Main outcomes and measures: The primary outcome was favorable neurological outcome at 28 days defined as cerebral performance category 1 or 2. A noninferiority margin of 1% was chosen. Secondary end points included rate of survival to hospital admission, rate of survival at day 28, rate of return of spontaneous circulation, and ETI and BMV difficulty or failure.

Results: Among 2043 patients who were randomized (mean age, 64.7 years; 665 women [32%]), 2040 (99.8%) completed the trial. In the intention-to-treat population, favorable functional survival at day 28 was 44 of 1018 patients (4.3%) in the BMV group and 43 of 1022 patients (4.2%) in the ETI group (difference, 0.11% [1-sided 97.5% CI, -1.64% to infinity]; P for noninferiority = .11). Survival to hospital admission (294/1018 [28.9%] in the BMV group vs 333/1022 [32.6%] in the ETI group; difference, -3.7% [95% CI, -7.7% to 0.3%]) and global survival at day 28 (55/1018 [5.4%] in the BMV group vs 54/1022 [5.3%] in the ETI group; difference, 0.1% [95% CI, -1.8% to 2.1%]) were not significantly different. Complications included difficult airway management (186/1027 [18.1%] in the BMV group vs 134/996 [13.4%] in the ETI group; difference, 4.7% [95% CI, 1.5% to 7.9%]; P = .004), failure (69/1028 [6.7%] in the BMV group vs 21/996 [2.1%] in the ETI group; difference, 4.6% [95% CI, 2.8% to 6.4%]; P < .001), and regurgitation of gastric content (156/1027 [15.2%] in the BMV group vs 75/999 [7.5%] in the ETI group; difference, 7.7% [95% CI, 4.9% to 10.4%]; P < .001).

Conclusions and relevance: Among patients with out-of-hospital cardiorespiratory arrest, the use of BMV compared with ETI failed to demonstrate noninferiority or inferiority for survival with favorable 28-day neurological function, an inconclusive result. A determination of equivalence or superiority between these techniques requires further research.

Trial registration: clinicaltrials.gov Identifier: NCT02327026.

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Conflict of interest statement

Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Heidet reported receiving personal fees from AstraZeneca outside of the submitted work. Dr Lapostolle reported receiving grants, personal fees, and/or nonfinancial support from AstraZeneca, Boehringer-Ingelheim, Bayer, Lilly, Correvio, Daiichi-Sankyo, The Medicines Company, MundiPharma, and Pfizer during the conduct of the study and from Merck-Serono, Roche, and Teleflex outside the submitted work. Dr Reuter reported receiving personal fees from AstraZeneca outside the submitted work. Dr Vicaut reported receiving personal fees from Abbott, Boehringer-Ingelheim, Bristol Myers-Squibb, Celgene, the European Cardiovascular Research Center, Fresenius, Laboratoire Français de fractionnement et des Biotechnologies, Lilly, Medtronic, Novartis, Pfizer, and Sanofi and a grant from Sanofi outside the submitted work. Dr Adnet reported receiving personal fees from Novartis outside the submitted work. No other disclosures were reported.

Figures

Figure.
Figure.. Flow Chart of Patient Inclusion
The number of patients assessed for eligibility was not available. BMV indicates bag-mask ventilation; ETI, endotracheal intubation; ITT, intention to treat; PP, per protocol; and ROSC, return of spontaneous circulation. aSeveral reasons may be present for the same patient.
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