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