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

Arabi, Yaseen M; Tlayjeh, Haytham; Aldekhyl, Sara; Al-Dorzi, Hasan M; Abdukahil, Sheryl Ann; Al Harbi, Mohammad Khulaif; Al Haji, Husain; Al Mutairi, Mohammed; Al Zumai, Omar; Al Qasim, Eman; Al Wehaibi, Wedyan; Al Qahtani, Saad; Al-Hameed, Fahad; Chalabi, Jamal; Alshahrani, Mohammed; Albrahim, Talal; Alharthy, Abdulrahman; Mady, Ahmed; Bin Eshaq, Abdulhadi; Al bshabshe, Ali A; Al Aseri, Zohair; Al Duhailib, Zainab; Kharaba, Ayman; Alqahtani, Rakan; Al Ghamdi, Adnan; Altalag, Ali; Alghamdi, Khalid; Almaani, Mohammed; Algethamy, Haifa; Al Aqeily, Ahmad; Al Baseet, Faisal; Al Samannoudi, Hashem; Al Obaidi, Mohammed; Ismaiel, Yassin T; Al-Fares, Abdulrahman A

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.