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

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

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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

Article activity feed

  1. Version published to 10.1186/s13063-021-05988-x
  2. ScreenIT

    SciScore for 10.1101/2021.07.26.21260421: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    EthicsIRB: The study has been approved by the Institutional Review Boards of the participating sites.
    Consent: Post- enrollment exclusion from the intention-to-treat analysis will be restricted to the withdrawal of consent to use trial data by the patient or surrogate decision-maker (SDM) or wrong randomization.
    Sex as a biological variablenot detected.
    RandomizationWe will report the number of patients who were randomized to each group, received the allocated intervention, and included in the final analysis.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    No key resources detected.

    Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).

    Results from LimitationRecognizer: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.

    Results from TrialIdentifier: We found the following clinical trial numbers in your paper:

    IdentifierStatusTitle
    NCT04477668RecruitingHelmet Non-Invasive Ventilation for COVID-19 Patients

    Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

    Results from JetFighter: We did not find any issues relating to colormaps.

    Results from rtransparent:
    • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
    • No protocol registration statement was detected.

    Results from scite Reference Check: We found no unreliable references.

    About SciScore

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  3. Version published to 10.1101/2021.07.26.21260421v1 on medRxiv