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. 2021 Aug 26;11(8):e052169.
doi: 10.1136/bmjopen-2021-052169.

Helmet Non-Invasive Ventilation for COVID-19 Patients (Helmet-COVID): study protocol for a multicentre randomised controlled trial

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

Helmet Non-Invasive Ventilation for COVID-19 Patients (Helmet-COVID): study protocol for a multicentre randomised controlled trial

Yaseen M Arabi et al. BMJ Open. .

Abstract

Introduction: Non-invasive ventilation (NIV) delivered by helmet has been used for respiratory support of patients with acute hypoxaemic respiratory failure due to COVID-19 pneumonia. The aim of this study was to compare helmet NIV with usual care versus usual care alone to reduce mortality.

Methods and analysis: This is a multicentre, pragmatic, parallel randomised controlled trial that compares helmet NIV with usual care to usual care alone in a 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 of each participating institution. Our findings will be published in peer-reviewed journals and presented at relevant conferences and meetings.

Trial registration number: NCT04477668.

Keywords: COVID-19; adult intensive & critical care; respiratory medicine (see thoracic medicine).

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Conflict of interest statement

Competing interests: None declared.

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