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עברית
A Cluster Randomized Clinical Trial
Findings In this cluster randomized clinical trial, a total of 968 patients who experienced out-of-hospital cardiac arrest were enrolled. There was no significant difference between the 2 groups, in which the proportion of sustained return of spontaneous circulations was 26.9% in the endotracheal intubation group and 25.8% in the supraglottic airway group.
Meaning This clinical trial showed no difference in the rates of sustained return of spontaneous circulation in initial prehospital airway management with the placement of a supraglottic airway vs endotracheal intubation.
Importance Prehospital advanced airway management with either initial endotracheal intubation (ETI) or initial supraglottic airway (SGA) insertion in patients with out-of-hospital cardiac arrest (OHCA) remains controversial.
Objective To compare the effectiveness of ETI and SGA in patients with nontraumatic OHCA.
Design, Setting, and Participants The Supraglottic Airway Device vs Endotracheal intubation (SAVE) trial was a multicenter cluster randomized clinical trial conducted in Taipei City, Taiwan. Individuals aged 20 years or older who experienced nontraumatic OHCA requiring advanced airway management and were treated by participating emergency medical service agencies were enrolled from November 11, 2016, to December 31, 2019. The final day of follow-up was February 19, 2020.
Interventions Four advanced life support ambulance teams were divided into 2 randomization clusters, with each cluster assigned to either ETI or SGA in a biweekly period.
Main Outcomes and Measures The primary outcome of the SAVE trial was sustained return of spontaneous circulation (ROSC) (≥2 hours) after resuscitation. Secondary outcomes included prehospital ROSC, survival to hospital discharge, and favorable neurologic outcome, defined as a cerebral performance category score less than or equal to 2. Prespecified subgroups and the association between time to advanced airways were explored. Per protocol and intention-to-treat analysis were performed.
Results A total of 936 patients (517 in the ETI group and 419 in the SGA group) were included in the primary analysis (median age, 77 [IQR, 62-85] years; 569 men [60.8%]). The first-attempt airway success rates were 77% with ETI (n = 413) and 83% with SGA (n = 360). Sustained ROSC was 26.9% (n = 139) in the ETI group vs 25.8% (n = 108) in the SGA group. The odds ratio of sustained ROSC was 1.02 (95% CI, 0.98-1.06) in the ETI group vs SGA group. The odds ratio of ETA vs SGA was 1.04 (95% CI, 1.02-1.07) for prehospital ROSC, 1.00 (95% CI, 0.94-1.06) for survival to hospital discharge, and 0.99 (95% CI, 0.94-1.03) for cerebral performance category scores less than or equal to 2.
Conclusions and Relevance In this randomized clinical trial, among patients with OHCA, initial airway management with ETI did not result in a favorable outcome of sustained ROSC compared with SGA device insertion.
