Effect of Placement of a Supraglottic Airway Device vs Endotracheal Intubation on Return of Spontaneous Circulation in Adults With Out-of-Hospital Cardiac Arrest in Taipei, Taiwan: A Cluster Randomized Clinical Trial

An-Fu Lee, Yu-Chun Chien, Bin-Chou Lee, Wen-Shuo Yang, Yao-Cheng Wang, Hao-Yang Lin, Edward Pei-Chuan Huang, Kah-Meng Chong, Jen-Tang Sun, Matthew Huei-Ming, Ming-Ju Hsieh, Wen-Chu Chiang, An-Fu Lee, Yu-Chun Chien, Bin-Chou Lee, Wen-Shuo Yang, Yao-Cheng Wang, Hao-Yang Lin, Edward Pei-Chuan Huang, Kah-Meng Chong, Jen-Tang Sun, Matthew Huei-Ming, Ming-Ju Hsieh, Wen-Chu Chiang

Abstract

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.

Trial registration: ClinicalTrials.gov Identifier: NCT02967952.

Conflict of interest statement

Conflict of Interest Disclosures: None reported.

Figures

Figure 1.. Flowchart of the Study Patients
Figure 1.. Flowchart of the Study Patients
BVM indicates bag-valve-mask; ETI, endotracheal intubation; SGA, supraglottic airway. aPreexisting condition, such as mouth cannot be opened wide enough for laryngoscope insertion. bPreexisting condition, such as tracheostomy.
Figure 2.. The Association Between the Probability…
Figure 2.. The Association Between the Probability of Outcomes and Call to Airway Time
Findings were nonsignificant for sustained return of spontaneous circulation (ROSC), P = .44 (A); significant for prehospital ROSC, P = .03 (B); nonsignificant for survival to hospital discharge, P = .82 (C); and nonsignificant for cerebral performance category (CPC) score less than or equal to 2, P = .67 (D). ETI indicates endotracheal intubation; SGA, supraglottic airway.

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