Abstract
BackgroundNoninvasive 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.MethodsIn 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.DiscussionWe 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 registrationClinicalTrials.govNCT04477668. Registered on July 20, 2020
Highlights
Noninvasive respiratory support is frequently needed for patients with acute hypoxemic respiratory failure due to coronavirus disease 19 (COVID-19)
We describe the statistical analysis plan (SAP) of the Helmet-COVID trial
Sensitivity analyses We will compare the primary outcome between the helmet noninvasive ventilation (NIV) and usual care groups in the per-protocol cohorts
Summary
Noninvasive respiratory support is frequently needed for patients with acute hypoxemic respiratory failure due to coronavirus disease 19 (COVID-19). As invasive mechanical ventilation carries high morbidity and mortality, other respiratory modalities, such as high-flow nasal oxygen (HFNO) and noninvasive ventilation (NIV) delivered via face mask or helmet, have been suggested and increasingly practiced. A randomized controlled trial (RCT) compared the early application of 48 h of helmet NIV to high-flow nasal oxygen (HFNO) in 109 patients with moderate to severe hypoxemia (ratio of partial pressure of arterial oxygen to fraction of inspired oxygen (PaO2:FiO2) ratio ≤ 200) and showed no difference in the number of days free of respiratory support at 28 days (primary outcome) with a significantly lower incidence of intubation and a higher number of invasive mechanical ventilation-free days at 28 days in the helmet NIV group [10]
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have