Dataset Information

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

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.

SUBMITTER: Arabi YM

PROVIDER: S-EPMC8392742 | biostudies-literature | 2021 Aug

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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

Arabi Yaseen M YM Tlayjeh Haytham H Aldekhyl Sara S Al-Dorzi Hasan M HM Abdukahil Sheryl Ann SA Al Harbi Mohammad Khulaif MK Al Haji Husain H Al Mutairi Mohammed M Al Zumai Omar O Al Qasim Eman E Al Wehaibi Wedyan W Al Qahtani Saad S Al-Hameed Fahad F Chalabi Jamal J Alshahrani Mohammed M Albrahim Talal T Alharthy Abdulrahman A Mady Ahmed A Bin Eshaq Abdulhadi A Al Bshabshe Ali A AA Al Aseri Zohair Z Al Duhailib Zainab Z Kharaba Ayman A Alqahtani Rakan R Al Ghamdi Adnan A Altalag Ali A Alghamdi Khalid K Almaani Mohammed M Algethamy Haifa H Al Aqeily Ahmad A Al Baseet Faisal F Al Samannoudi Hashem H Al Obaidi Mohammed M Ismaiel Yassin T YT Al-Fares Abdulrahman A AA

BMJ open 20210826 8

<h4>Introduction</h4>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.<h4>Methods and analysis</h4>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 ...[more]

PMID: 34446500

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Project description:IntroductionLow pressure nasal continuous positive airway pressure (nCPAP) has long been the mainstay of non-invasive respiratory support for preterm neonates, at a constant distending pressure of 5-8 cmH2O. When traditional nCPAP pressures are insufficient, other modes including nasal intermittent positive pressure ventilation (NIPPV) are used. In recent years, high nCPAP pressures (≥9 cmH2O) have also emerged as an alternative. However, the comparative benefits and risks of these modalities remain unknown.Methods and analysisIn this multicentre pilot randomised controlled trial, infants <29 weeks' gestational age (GA) who either: (A) fail treatment with traditional nCPAP or (B) being extubated from invasive mechanical ventilation with mean airway pressure ≥10 cmH2O, will be randomised to receive either high nCPAP (positive end-expiratory pressure 9-15 cmH2O) or NIPPV (target mean Paw 9-15 cmH2O). Primary outcome is feasibility of the conduct of a larger, definitive trial as assessed by rates of recruitment and protocol violations. The main secondary outcome is failure of assigned treatment within 7 days postrandomisation. Multiple other clinical outcomes including bronchopulmonary dysplasia will be ascertained. All randomised participants will be analysed using intention to treat. Baseline and demographic variables as well as outcomes will be summarised and compared using univariate analyses, and a p<0.05 will be considered significant.Ethics and disseminationThe trial has been approved by the respective research ethics boards at each institution (McMaster Children's Hospital: Hamilton integrated REB approval #2113; Royal Alexandra Hospital: Health Research Ethics Board approval ID Pro00090244; Westmead Hospital: Human Research Ethics Committee approval ID 2022/ETH01343). Written, informed consent will be obtained from all parents/guardians prior to study enrolment. The findings of this pilot study will be disseminated via presentations at national and international conferences and via publication in a peer-reviewed journal. Social media platforms including Twitter will also be used to generate awareness.Trial registration numberNCT03512158.

Project description:IntroductionPatients with obesity are considered to be at high risk of acute respiratory failure (ARF) after extubation in intensive care unit (ICU). Compared with oxygen therapy, non-invasive ventilation (NIV) may prevent ARF in high-risk patients. However, these strategies have never been compared following extubation of critically ill patients with obesity. Our hypothesis is that NIV is associated with less treatment failure compared with oxygen therapy in patients with obesity after extubation in ICU.Methods and analysisThe NIV versus oxygen therapy after extubation in patients with obesity in ICUs protocol (EXTUB-obese) trial is an investigator-initiated, multicentre, stratified, parallel-group unblinded trial with an electronic system-based randomisation. Patients with obesity defined as a body mass index ≥30 kg/m² will be randomly assigned in the 'NIV-group' to receive prophylactic NIV applied immediately after extubation combined with high-flow nasal oxygen (HFNO) or standard oxygen between NIV sessions versus in the 'oxygen therapy group' to receive oxygen therapy alone (HFNO or standard oxygen,). The primary outcome is treatment failure within the 72 hours, defined as reintubation for mechanical ventilation, switch to the other study treatment, or premature study-treatment discontinuation (at the request of the patient or for medical reasons such as gastric distention). The single, prespecified, secondary outcome is the incidence of ARF until day 7. Other outcomes analysed will include tracheal intubation rate at day 7 and day 28, length of ICU and hospital stay, ICU mortality, day 28 and day 90 mortality.Ethics and disseminationThe study project has been approved by the appropriate ethics committee 'Comité-de-Protection-des-Personnes Ile de FranceV-19.04.05.70025 Cat2 2019-A00956-51'. Informed consent is required. The results will be submitted for publication in a peer-reviewed journal and presented at one or more scientific conferences. If use of NIV shows positive effects, teams (medical and surgical) will use NIV following extubation of critically ill patients with obesity.Trial registration numberNCT04014920.

Dataset Information

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

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

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

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