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Helmet Non-Invasive Ventilation for COVID-19 Patients (Helmet-COVID): study protocol for a multicentre randomised
Yaseen M Arabi1,2, Haytham Tlayjeh3,2, Sara Aldekhyl3,2
1Intensive Care Department, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia yaseenarabi@yahoo.com.
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.
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