Helmet noninvasive ventilation for COVID-19 patients “Helmet-COVID”: study protocol for a multicenter randomized controlled trial

  1. Yaseen Arabi
  2. Haytham Tlayjeh
  3. Sara Aldekhyl
  4. Hasan M Al-Dorzi
  5. Sheryl Ann Abdukahil
  6. Mohammad Khulaif Al Harbi
  7. Husain Al Haji
  8. Mohammed Al Mutairi
  9. Omar Al Zumai
  10. Eman Al Qasim
  11. Wedyan Al Wehaibi
  12. Saad Al Qahtani
  13. Fahad Al-Hameed
  14. Jamal Chalabi
  15. Mohammed Alshahrani
  16. Abdulrahman Alharthy
  17. Ahmed Mady
  18. Abdulhadi Bin Eshaq
  19. Ali Al Bshabshe
  20. Zohair Al Aseri
  21. Zainab Al Duhailib
  22. Ayman Kharaba
  23. Rakan Alqahtani
  24. Adnan Al Ghamdi
  25. Ali Altalag
  26. Khalid Alghamdi
  27. Mohammed Almaani
  28. Haifa Algethamy
  29. Ahmad Al Aqeily
  30. Faisal Al Baseet
  31. Hashem Al Samannoudi
  32. Mohammed Al Obaidi
  33. Yassin Ismaiel
  34. Abdulrahman A Al-Fares

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Abstract

Introduction

Noninvasive ventilation delivered by helmet is has been used for respiratory support of patients with acute hypoxemic respiratory failure due to COVID-19 pneumonia. The aim of this study is to compare helmet noninvasive ventilation with usual care versus usual care alone to reduce the mortality.

Methods and analysis

This is a multicenter, pragmatic, parallel, randomized controlled trial that compares helmet noninvasive ventilation with usual care to usual care alone in 1:1 ratio. A total of 320 patients will be enrolled in this study. The primary outcome is 28-day all-cause mortality. The primary outcome will be compared between the two study groups in the intention-to-treat and per-protocol cohorts. An interim analysis will be conducted for both safety and effectiveness.

Ethics and dissemination

Approvals are obtained from the Institutional Review Boards (IRBs) of each participating institution. Our findings will be published in peer-review journals and presented at relevant conferences and meetings.

Trial registration number

NCT04477668 registered on July 20, 2020

Article Summary

Strengths and limitations of this study

  • This trial compares helmet NIV to usual care for respiratory support of patients with acute hypoxemic respiratory failure due to COVID-19 pneumonia.

  • The trial is a multi-center, pragmatic, parallel randomized controlled trial.

  • The main limitation is the unblinded design due to the nature of the intervention.

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  1. ScreenIT

    SciScore for 10.1101/2021.08.04.21260420: (What is this?)

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

    Table 1: Rigor

    EthicsConsent: Informed consent: Informed consent will be obtained from the potential trial participants or their surrogate decision makers.
    Sex as a biological variablenot detected.
    RandomizationTrial interventions: Helmet group: A helmet (Subsalve, USA or its equivalent), which is made of transparent latex-free polyvinyl chloride, will be applied to patients randomized to the intervention group as per the study protocol which considers the manufacturer instructions.
    BlindingBlinding: Due to the nature of the study intervention, blinding is not be possible.
    Power Analysis22 Considering a mortality rate of 40% in patients with COVID-19 pneumonia and moderate to severe ARDS treated with usual care, we calculated that enrollment of 304 patients (152 in each group) would provide the study with 80% power to demonstrate an absolute difference of 15% in the primary outcome between the usual care group and helmet NIV group at a two-sided alpha level of 0.05.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    SAS software, version 9.2 (SAS Institute) will be used for all the analyses.
    SAS Institute
    suggested: (Statistical Analysis System, RRID:SCR_008567)

    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: We detected the following sentences addressing limitations in the study:
    The main limitation to our study is inability to blind the given allocation due to the nature of the intervention.

    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

    SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore checks for the presence and correctness of RRIDs (research resource identifiers), and for rigor criteria such as sex and investigator blinding. For details on the theoretical underpinning of rigor criteria and the tools shown here, including references cited, please follow this link.

  2. Version published to 10.1101/2021.08.04.21260420v1 on medRxiv
  3. Version published to 10.1136/bmjopen-2021-052169