Exploration of alive-and-ventilator free days as an outcome measure for clinical trials of Resuscitative interventions

Ari Moskowitz, Xianhong Xie, Michelle Ng Gong, Henry E Wang, Luke Andrea, Yungtai Lo, Mimi Kim and for the Hospital Airway Resuscitation Trial Investigators

PLOS ONE, 2024, vol. 19, issue 7, 1-13

Abstract: Background: Outcome selection is a critically important aspect of clinical trial design. Alive-and-ventilator free days is an outcome measure commonly used in critical care clinical trials, but has not been fully explored in resuscitation science. Methods: A simulation study was performed to explore approaches to the definition and analysis of alive-and-ventilator free days in cardiac arrest populations. Data from an in-hospital cardiac arrest observational cohort and from the Pragmatic Airway Resuscitation Trial were used to inform and conduct the simulations and validate approaches to alive-and-ventilator free days measurement and analysis. Findings: Alive-and-ventilator-free days is a flexible outcome measure in cardiac arrest populations. An approach to alive-and-ventilator free days that assigns -1 days when return of spontaneous circulation is not achieved provides a wider distribution of the outcome and improves statistical power. The optimal approach to the analysis of alive-and-ventilator free days varies based on the expected impact of the intervention under study on rates of return of spontaneous circulation, survival, and ventilator-free survival. Conclusions: Alive-and-ventilator free days adds to the armamentarium of clinical trialists in the field of resuscitation science.

Date: 2024
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Persistent link: https://EconPapers.repec.org/RePEc:plo:pone00:0308033

DOI: 10.1371/journal.pone.0308033

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