• Resuscitation · Oct 2022

    Pragmatic Clinical Trial

    Assessment of Intensive Care Unit-Free and Ventilator-Free Days as Alternative Outcomes in the Pragmatic Airway Resuscitation Trial.

    • Henry E Wang, Ashish Panchal, Madison HyerJJThe Ohio State University, United States. Electronic address: madison.hyer@osumc.edu., Graham Nichol, Clifton W Callaway, Tom Aufderheide, Michelle Nassal, Vanden HoekTerryTUniversity of Illinois at Chicago, United States. Electronic address: tvh@uic.edu., Jing Li, Mohamud R Daya, Matthew Hansen, Robert H Schmicker, Ahamed Idris, and Lai Wei.
    • The Ohio State University, United States. Electronic address: henry.wang@osumc.edu.
    • Resuscitation. 2022 Oct 1; 179: 50-58.

    ObjectiveWe sought to evaluate the utility and validity of ICU-free days and ventilator-free days as candidate outcomes for OHCA trials.MethodsWe conducted a secondary analysis of the Pragmatic Airway Resuscitation Trial. We determined ICU-free (days alive and out of ICU during the first 30 days) and ventilator-free days (days alive and without mechanical ventilation). We determined ICU-free and ventilator-free day distributions and correlations with Modified Rankin Scale (MRS). We tested associations with trial interventions (laryngeal tube (LT), endotracheal intubation (ETI)) using continuous (t-test), non-parametric (Wilcoxon Rank-Sum test - WRS), count (negative binomial - NB) and survival models (Cox proportional hazards (CPH) and competing risks regression (CRR)). We conducted bootstrapped simulations to estimate statistical power.Main ResultsICU-free days was skewed; median 0 days (IQR 0, 0), survivors only 24 (18, 27). Ventilator-free days was skewed; median 0 (IQR 0, 0) days, survivors only 27 (IQR 23, 28). ICU-free and ventilator-free days correlated with MRS (Spearman's ρ = -0.95 and -0.97). LT was associated with higher ICU-free days using t-test (p = 0.001), WRS (p = 0.003), CPH (p = 0.02) and CRR (p = 0.04), but not NB (p = 0.13). LT was associated with higher ventilator-free days using t-test (p = 0.001), WRS (p = 0.001) and CRR (p = 0.03), but not NB (p = 0.13) or CPH (p = 0.13). Simulations suggested that t-test and WRS would have had the greatest power to detect the observed ICU- and ventilator-free days differences.ConclusionICU-free and ventilator-free days correlated with MRS and differentiated trial interventions. ICU-free and ventilator-free days may have utility in the design of OHCA trials.Copyright © 2022 Elsevier B.V. All rights reserved.

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