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

02 February 2022

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doi: 10.1186/s13063-021-05988-x

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.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1 CONSORT flow diagram

Fig. 1 CONSORT flow diagram

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