A European, multicenter, randomized controlled trial

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Presentation transcript:

A European, multicenter, randomized controlled trial INITIAL AIRWAY MANAGEMENT IN PATIENTS WITH OUT-OF-HOSPITAL CARDIAC ARREST: TRACHEAL INTUBATION VS. BAG-MASK VENTILATION. A European, multicenter, randomized controlled trial CAAM TIAL Frédéric Adnet Samu 93 – Urgences – Inserm U942 Avicenne Universitary Hospital 93000 Bobigny, France Trial funded by French Ministry of Health (PHRC 2013) BVM vs. Intubation in OHCA patients: CAAM Trial

Rationale Benefit of endotracheal intubation (ETI) during CPR is unclear. Observational studies suggest Bag-Mask ventilation (BMV) is associated with better survival than ETI Quasi-randomized trial in children suggested no significant difference in survival or neurologic outcome with ETI vs. BMV

Hypothesis Bag-Mask Ventilation (BMV) is less complex technique than ETI, appears to be safe and may avoid adverse effects of tracheal intubation (ETI) during CPR We conducted a non-inferiority, multicenter, randomized controlled trial of BMV versus ETI.

Design Primary Outcome: survival to 28 days with good neurological outcome. Secondary outcomes included ROSC, survival at hospital admission, adverse effects. 1000 patients per arm is required to have 80% power to demonstrate non-inferiority with margin fixed at 1%.

Study Setting: 20 pre-hospital emergency medical services centers (SAMU): 15 in France and 5 in Belgium

ballet.alain@neuf.fr Baseline Characteristics (ITT population = 2040) BMV group (N=1018) ETI group (N=1022) Age – yr, mean ±SD 65.7±15.5 63.8±15.6 Female gender – no. (%) 332 (32.6) 332 (32.5) Arrest occurring at home – no. (%) 776 (76.2) 811 (79.4) Bystander witnessed – no. (%) 719 (70.6) 708 (69.3) Shockable first rhythm – no. (%) 168 (16.5) 155 (15.2) Number of shocks – median (interquartile range) 3 (1, 7) 3 (1, 6)

Primary outcome (ITT analysis) BMV (N=1018) ETI (N=1022) Difference [95% CI] Survival with good neurological status at day 28 N= 42 (4.2%) N= 43 (4.3%) 0.11 [-1.64; 1.87] 1% Intubation group better BVM group better

Outcomes (ITT analysis) BMV group (N=1018) ETI group (N=1022) P value Return of spontaneous circulation – no. (%) 348 (34.2) 397 (38.9) 0.03 Survival at hospital admission– no. (%) 294 (28.9) 333 (32.6) 0.07 Survival at day 28 – no. (%) 55 (5.4) 54 (5.3) 0.90

Safety analysis BMV or ETI failure – no. (%) 64 (6.3) 26 (2.5) Item BMV group (N=1028) ETI group (N=1001) p BMV or ETI failure – no. (%) 64 (6.3) 26 (2.5) <0.0001 BMV or ETI difficulty – no. (%) 186 (18.1) 134 (13.4) 0.004 Regurgitation of gastric content 152 (14.9) 79 (7.7)

Conclusion Our trial was inconclusive regarding the demonstration of non-inferiority of BMV compared with TI for airway management during CPR in OHCA patients However, this randomized study did not confirm superiority of BMV reported in observational studies On the other hand, BMV is associated with increased complications and difficulty.