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

Abstract

IntroductionNon-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 analysisThis 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 disseminationApprovals 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 numberNCT04477668.

Long-term outcomes of patients with COVID-19 treated with helmet noninvasive ventilation or usual respiratory support: follow-up study of the Helmet-COVID randomized clinical trial

“…The Helmet-COVID trial was an investigator-initiated, pragmatic, multicenter randomized controlled trial conducted between 8 February 2021 and 16 November 2021 across seven sites in Saudi Arabia and 1 in Kuwait (Table S1) [ 9 – 11 ]. A priori or deferred written or witnessed verbal consent was obtained from all patients or surrogates per local approvals.…”

“…Eligible patients were randomly allocated to receive helmet noninvasive ventilation or usual respiratory support. In the helmet noninvasive ventilation group, pressure support was applied through a helmet (Subsalve, Middletown, Rhode Island) according to a written protocol, with initial settings of pressure support of 8–10 cmH 2 O, positive end-expiratory pressure (PEEP) of 10 cmH 2 O with FiO 2 of 1, a flow rate of ≥ 50 L/min, an inspiratory rise time of 50 ms and end flow/cycling off of 50% of maximal inspiratory flow [ 9 – 11 ]. Interruptions of the helmet were avoided or kept at a minimum at least in the first 48 h [ 9 – 11 ].…”

“…The Helmet-COVID trial evaluated whether helmet noninvasive ventilation compared with usual respiratory support would reduce 28-day all-cause mortality in patients with acute hypoxemic respiratory failure due to COVID-19 [ 9 – 11 ] and demonstrated that helmet noninvasive ventilation did not significantly reduce 28-day mortality [ 11 ]. In this report, we present the 180-day mortality and HRQoL results, which were pre-specified secondary outcome measures of the Helmet-COVID trial.…”

High-Flow Nasal Oxygen and Noninvasive Ventilation for COVID-19

“…Multiple RCTs on noninvasive respiratory support in patients with COVID-19 are ongoing (Table 2). 60 These trials are addressing the effectiveness of HFNO, facemask NIV, and helmet NIV. Other studies are needed to evaluate the safety and effectiveness of noninvasive respiratory support outside of the ICU setting and validate the predictors of success or failure of HFNO and NIV.…”

Aerosol Generating Procedures-How to Manage?

“…Helmet NIV can be used as it is sealed and closed space in helmet which minimize aerosol spread. However disadvantages with Helmet NIV is increase in dead space, claustrophobia, difficulty in suction and feeding etc, so it is not much popular [5,6] (Figure 1).…”