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- Title
Helmet noninvasive ventilation for COVID-19 patients (Helmet-COVID): statistical analysis plan for a randomized controlled trial.
- Authors
Arabi, Yaseen; Aldekhyl, Sara; Al Qahtani, Saad; Al-Dorzi, Hasan M.; Abdukahil, Sheryl Ann; Jose, Jesna; Al Harbi, Mohammad Khulaif; Al Haji, Husain; Al Mutairi, Mohammed; Al Zumai, Omar; Al Qasim, Eman; Al Wehaibi, Wedyan; Alshahrani, Mohammed; Albrahim, Talal; Mady, Ahmed; Al Bshabshe, Ali; Al Aseri, Zohair; Al Duhailib, Zainab; Kharaba, Ayman; Alqahtani, Rakan
- Abstract
<bold>Background: </bold>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.<bold>Methods: </bold>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.<bold>Discussion: </bold>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.<bold>Trial Registration: </bold>ClinicalTrials.gov NCT04477668 . Registered on July 20, 2020.
- Publication
Trials, 2022, Vol 23, Issue 1, p1
- ISSN
1745-6215
- Publication type
Article
- DOI
10.1186/s13063-021-05988-x