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JAMA. 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.

Author information

1
AP-HP, Service d'Aide Médicale d'Urgence (SAMU) de Paris and Paris Sudden Death Expertise Center, Université Paris Descartes, Paris, France.
2
Emergency Department, Cliniques universitaires Saint Luc, Université Catholique de Louvain, Brussels, Belgium.
3
SAMU de Lyon and Department of Emergency Medicine, Hospices Civils de Lyon, Edouard Herriot Hospital, Lyon, France.
4
AP-HP, Emergency Medical Service Department, Beaujon University Hospital, Clichy, France.
5
Department of Emergency Medicine, Texas Tech University Health Sciences Center, El Paso.
6
SAMU 44, Department of Emergency Medicine, University Hospital of Nantes, Nantes, France.
7
SAMU 78, Centre Hospitalier de Versailles, Le Chenay, France.
8
Service des Urgences et du Service Mobile d'Urgence et de Réanimation (SMUR), CHU Saint-Pierre, Brussels, Belgium.
9
SAMU 36, CH de Chateauroux, Chateauroux, France.
10
SAMU 95, Centre Hospitalier René Dubos, Pontoise, France.
11
AP-HP, SAMU 94, Hôpital Henri Mondor, Université Paris-Est Créteil, EA-4330, Créteil, France.
12
SAMU, Hôpital Central, CHU Nancy, Nancy Cedex, France.
13
SAMU 82, Hôpital de Montauban, Montauban, France.
14
SAMU, The Mercy Regional Hospital Centre (CHR) of Metz-Thionville, Ars-Laquenexy, France.
15
Emergency Department, Cliniques universitaires Saint Luc, Université Catholique de Louvain, Belgium.
16
SMUR Saint Denis, Hôpital Delafontaine, Saint Denis, France.
17
SAMU 974, CHU Félix Guyon-St Denis de la Réunion, France.
18
CHU Brugmann, Brussels, Belgium.
19
CHR Namur, Namur, Belgium.
20
SMUR, Hôpital de Quimper, Quimper, France.
21
AP-HP, SMUR Pitié, Hôpital Pitié-Salpétrière, Paris, France.
22
AP-HP, SMUR Hôtel-Dieu, hôpital Hôtel-Dieu, Paris, France.
23
AP-HP, SAMU 93, Hôpital Avicenne, Inserm U942, Bobigny, France.
24
AP-HP, Urgences, Hôpital Louis Mourier, Colombes, France.
25
AP-HP, SAMU 92, Hôpital Raymond Poincaré, Garches, France.
26
AP-HP, Unité de Recherche Clinique, hôpital Fernand Widal, Université Paris-Diderot, Paris, France.

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.

PMID:
29486039
PMCID:
PMC5838565
DOI:
10.1001/jama.2018.0156
[Indexed for MEDLINE]
Free PMC Article

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