Background Noninvasive respiratory support is frequently needed for patients with acute hypoxemic respiratory failure due to coronavirus disease 19 (COVID-19). Helmet noninvasive ventilation has multiple advantages over other oxygen support modalities but data about effectiveness are limited. Methods In this multicenter randomized trial of helmet noninvasive ventilation for COVID-19 patients, 320 adult ICU patients (aged ≥14 years or as per local standards) with suspected or confirmed COVID-19 and acute hypoxemic respiratory failure (ratio of arterial oxygen partial pressure to fraction of inspired oxygen < 200 despite supplemental oxygen with a partial/non-rebreathing mask at a flow rate of 10 L/min or higher) will be randomized to helmet noninvasive ventilation with usual care or usual care alone, which may include mask noninvasive ventilation, high-flow nasal oxygen, or standard oxygen therapy. The primary outcome is death from any cause within 28 days after randomization. The trial has 80% power to detect a 15% absolute risk reduction in 28-day mortality from 40 to 25%. The primary outcome will be compared between the helmet and usual care group in the intention-to-treat using the chi-square test. Results will be reported as relative risk and 95% confidence interval. The first patient was enrolled on February 8, 2021. As of August 1, 2021, 252 patients have been enrolled from 7 centers in Saudi Arabia and Kuwait. Discussion We developed a detailed statistical analysis plan to guide the analysis of the Helmet-COVID trial, which is expected to conclude enrollment in November 2021. Trial registration ClinicalTrials.gov NCT04477668 . Registered on July 20, 2020 Supplementary Information The online version contains supplementary material available at 10.1186/s13063-021-05988-x.
【저자키워드】 COVID-19, Noninvasive ventilation, Helmet noninvasive ventilation, Statistical analysis plan, 【초록키워드】 coronavirus disease, coronavirus, Respiratory failure, Trial, randomization, randomized trial, 28-day mortality, Acute hypoxemic respiratory failure, High-flow nasal oxygen, Noninvasive ventilation, oxygen, Local, Relative risk, Saudi Arabia, Randomized, Patient, Effectiveness, death, Oxygen therapy, Kuwait, Intention, multicenter, respiratory, COVID-19 patients, Hypoxemic respiratory failure, Analysis, Respiratory Support, flow rate, chi-square test, partial pressure, oxygen partial pressure, supplemental oxygen, Enrollment, Primary outcome, Trial registration, supplementary material, 95% confidence interval, usual care, arterial oxygen partial pressure, standard oxygen therapy, fraction, usual care group, intention-to-treat, risk reduction, oxygen support, hypoxemic, ICU patient, Result, enrolled, detect, include, reported, expected, usual care alone, 【제목키워드】 Randomized controlled trial, COVID-19 patient,