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© 2024 Moskowitz et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.

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.

Details

Title
Exploration of alive-and-ventilator free days as an outcome measure for clinical trials of Resuscitative interventions
Author
Moskowitz, Ari  VIAFID ORCID Logo  ; Xie, Xianhong; Michelle Ng Gong; Wang, Henry E; Luke, Andrea; Lo, Yungtai; Kim, Mimi; for the Hospital Airway Resuscitation Trial Investigators
First page
e0308033
Section
Research Article
Publication year
2024
Publication date
Jul 2024
Publisher
Public Library of Science
e-ISSN
19326203
Source type
Scholarly Journal
Language of publication
English
ProQuest document ID
3086815713
Copyright
© 2024 Moskowitz et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.