Author: Chong Lei; Binxiao Su; Hailong Dong; Andrea Bellavia; Raffaele Di Fenza; Bijan Safaee Fakhr; Stefano Gianni; Luigi Giuseppe Grassi; Robert Kacmarek; Caio Cesar Araujo Morais; Riccardo Pinciroli; Emanuele Vassena; Lorenzo Berra
Title: Protocol of a randomized controlled trial testing inhaled Nitric Oxide in mechanically ventilated patients with severe acute respiratory syndrome in COVID-19 (SARS-CoV-2). Document date: 2020_3_13
ID: e99athff_23
Snippet: is the (which was not peer-reviewed) The copyright holder for this preprint [14] . We hypothesize that iNO gas may increase the PaO2/FiO2 ratio by at least 20% in the treatment group. Assuming an alpha of 0.05 and a beta (power) of 0.9, we calculated with a two-sample means test (Satterthwaite's t test assuming unequal variances) a need for N1=91 and N2=91 patients. A 10% of dropouts after ICU discharge is foreseen and sample size is thereby incr.....
Document: is the (which was not peer-reviewed) The copyright holder for this preprint [14] . We hypothesize that iNO gas may increase the PaO2/FiO2 ratio by at least 20% in the treatment group. Assuming an alpha of 0.05 and a beta (power) of 0.9, we calculated with a two-sample means test (Satterthwaite's t test assuming unequal variances) a need for N1=91 and N2=91 patients. A 10% of dropouts after ICU discharge is foreseen and sample size is thereby increased to N=200 patients. Estimated sample sizes where calculated using Stata 14.1 software.
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