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BMJ Open ; 11(8): e052169, 2021 08 26.
Article in English | MEDLINE | ID: covidwho-1376510

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.


Subject(s)
COVID-19 , Noninvasive Ventilation , Respiratory Insufficiency , Head Protective Devices , Humans , Multicenter Studies as Topic , Randomized Controlled Trials as Topic , Respiratory Insufficiency/therapy , SARS-CoV-2
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