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Randomized Controlled Trial
. 2022 Feb 2;23(1):105.
doi: 10.1186/s13063-021-05988-x.

Helmet noninvasive ventilation for COVID-19 patients (Helmet-COVID): statistical analysis plan for a randomized controlled trial

Yaseen Arabi  1 , Sara Aldekhyl  2 , Saad Al Qahtani  3 , Hasan M Al-Dorzi  3 , Sheryl Ann Abdukahil  3 , Jesna Jose  4 , Mohammad Khulaif Al Harbi  5 , Husain Al Haji  6 , Mohammed Al Mutairi  6 , Omar Al Zumai  6 , Eman Al Qasim  7 , Wedyan Al Wehaibi  3 , Mohammed Alshahrani  8 , Talal Albrahim  9 , Ahmed Mady  10   11 , Ali Al Bshabshe  12 , Zohair Al Aseri  13 , Zainab Al Duhailib  14 , Ayman Kharaba  15 , Rakan Alqahtani  16 , Haifa Algethamy  17 , Omar Alfaris  6 , Omar Alnafel  18 , Abdulrahman A Al-Fares  19 , Haytham Tlayjeh  3
Affiliations
Randomized Controlled Trial

Helmet noninvasive ventilation for COVID-19 patients (Helmet-COVID): statistical analysis plan for a randomized controlled trial

Yaseen Arabi et al. Trials. .

Abstract

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.

Keywords: COVID-19; Helmet noninvasive ventilation; Noninvasive ventilation; Statistical analysis plan.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
CONSORT flow diagram
See this image and copyright information in PMC

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