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Is bag-mask ventilation noninferior to endotracheal intubation for initial airway management during advanced resuscitation of patients with out-of-hospital cardiac arrest?
In this randomized clinical trial that included 2043 patients, favorable neurological function at 28 days was present in 4.3% in the bag-mask group vs 4.2% in the endotracheal intubation group, a difference that did not meet the noninferiority margin of 1%.
The study findings are inconclusive for noninferiority; further research would be necessary to assess equivalence or superiority.
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.
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.
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.
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.
clinicaltrials.gov Identifier: NCT02327026
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Corresponding Author: Frédéric Adnet, MD, PhD, AP-HP, SAMU 93, Hôpital Avicenne, Inserm U942, 93000 Bobigny, France (firstname.lastname@example.org).
Accepted for Publication: January 25, 2018.
Author Contributions: Drs Jabre and Vicaut had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Jabre, Manara, Vicaut, Adnet.
Acquisition, analysis, or interpretation of data: Jabre, Penaloza, Pinero, Duchateau, Borron, Javaudin, Richard, De Longueville, Bouilleau, Devaud, Heidet, Lejeune, Fauroux, Greingor, Hubert, Guihard, Vermylen, Lievens, Auffret, Maisondieu, Huet, Claessens, Lapostolle, Javaud, Reuter, Baker, Vicaut, Adnet.
Drafting of the manuscript: Borron, Richard, Bouilleau, Vermylen, Claessens, Javaud, Reuter, Baker, Vicaut, Adnet.
Critical revision of the manuscript for important intellectual content: Jabre, Penaloza, Pinero, Duchateau, Borron, Javaudin, De Longueville, Devaud, Heidet, Lejeune, Fauroux, Greingor, Manara, Hubert, Guihard, Lievens, Auffret, Maisondieu, Huet, Lapostolle, Javaud, Baker, Vicaut, Adnet.
Statistical analysis: Jabre, Fauroux, Vicaut.
Obtained funding: Fauroux, Vicaut, Adnet.
Administrative, technical, or material support: Penaloza, Bouilleau, Devaud, Lejeune, Fauroux, Hubert, Vermylen, Maisondieu, Huet, Lapostolle, Baker, Vicaut, Adnet.
Supervision: Greingor, Adnet.
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.
Group Information: Collaborators include Xavier Combes (La Réunion); Brigitte Hennequin (Hôpital Delafontaine); Elodie Honold-Lejeune (Hôpital Versailles); Fabien Tilhet (Hôpital Montauban); Carole Cornaglia (Hôpital); Charlotte Chollet-Xemard (Hôpital Henri Mondor); Philippe Delvaux (CHR Namur); Patrick Fusteur (Hôpital Edouard Herriot); Lionel Nace (Hôpital de Nancy); Agnès Ricard-Hibon (Hôpital de Pontoise); Magalie Bartiaux (Hôpital Saint Pierre); Sonia Ayllon-Milla (Hôpital Hotel Dieu); Arielle Beruben (Hôpital Montfermeil); Valérie Raphael (Hôpital Robert Ballanger); Philippe Meert (Brussels); Malha Mezaour (Hôpital Fernad Widal); and Amel Chamam (Hôpital Fernand Widal).
Funding/Support: This study was supported by the Programme Hospitalier de Recherche Clinique 2013 of the French Ministry of Health. The Assistance Publique Hôpitaux de Paris (AP-HP) is the key sponsor of this study, and by delegation the Department of Clinical Research and Development supervises all work in accordance with the French public health code.
Role of the Funder/Sponsor: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
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