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

doi: 10.1136/bmjopen-2021-052169

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).

Conflict of interest statement

Competing interests: None declared.

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