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Randomized Controlled Trial
. 2022 Sep 20;328(11):1063-1072.
doi: 10.1001/jama.2022.15599.

Effect of Helmet Noninvasive Ventilation vs Usual Respiratory Support on Mortality Among Patients With Acute Hypoxemic Respiratory Failure Due to COVID-19: The HELMET-COVID Randomized Clinical Trial

Yaseen M Arabi  1   2   3 , Sara Aldekhyl  1   2   3 , Saad Al Qahtani  1   2   3 , Hasan M Al-Dorzi  1   2   3 , Sheryl Ann Abdukahil  1   2   3 , Mohammed Khulaif Al Harbi  2   3   4 , Eman Al Qasim  1   2   3 , Ayman Kharaba  5 , Talal Albrahim  6 , Mohammed S Alshahrani  7 , Abdulrahman A Al-Fares  8 , Ali Al Bshabshe  9 , Ahmed Mady  10   11 , Zainab Al Duhailib  12 , Haifa Algethamy  13 , Jesna Jose  1   3   14 , Mohammed Al Mutairi  2   3   15 , Omar Al Zumai  2   3   15 , Hussain Al Haji  2   3   15 , Ahmed Alaqeily  2   3   15 , Zohair Al Aseri  16 , Awad Al-Omari  17 , Abdulaziz Al-Dawood  1   2   3 , Haytham Tlayjeh  1   2   3 ; Saudi Critical Care Trials Group
Collaborators, Affiliations
Randomized Controlled Trial

Effect of Helmet Noninvasive Ventilation vs Usual Respiratory Support on Mortality Among Patients With Acute Hypoxemic Respiratory Failure Due to COVID-19: The HELMET-COVID Randomized Clinical Trial

Yaseen M Arabi et al. JAMA. .

Abstract

Importance: Helmet noninvasive ventilation has been used in patients with COVID-19 with the premise that helmet interface is more effective than mask interface in delivering prolonged treatments with high positive airway pressure, but data about its effectiveness are limited.

Objective: To evaluate whether helmet noninvasive ventilation compared with usual respiratory support reduces mortality in patients with acute hypoxemic respiratory failure due to COVID-19 pneumonia.

Design, setting, and participants: This was a multicenter, pragmatic, randomized clinical trial that was conducted in 8 sites in Saudi Arabia and Kuwait between February 8, 2021, and November 16, 2021. Adult patients with acute hypoxemic respiratory failure (n = 320) due to suspected or confirmed COVID-19 were included. The final follow-up date for the primary outcome was December 14, 2021.

Interventions: Patients were randomized to receive helmet noninvasive ventilation (n = 159) or usual respiratory support (n = 161), which included mask noninvasive ventilation, high-flow nasal oxygen, and standard oxygen.

Main outcomes and measures: The primary outcome was 28-day all-cause mortality. There were 12 prespecified secondary outcomes, including endotracheal intubation, barotrauma, skin pressure injury, and serious adverse events.

Results: Among 322 patients who were randomized, 320 were included in the primary analysis, all of whom completed the trial. Median age was 58 years, and 187 were men (58.4%). Within 28 days, 43 of 159 patients (27.0%) died in the helmet noninvasive ventilation group compared with 42 of 161 (26.1%) in the usual respiratory support group (risk difference, 1.0% [95% CI, -8.7% to 10.6%]; relative risk, 1.04 [95% CI, 0.72-1.49]; P = .85). Within 28 days, 75 of 159 patients (47.2%) required endotracheal intubation in the helmet noninvasive ventilation group compared with 81 of 161 (50.3%) in the usual respiratory support group (risk difference, -3.1% [95% CI, -14.1% to 7.8%]; relative risk, 0.94 [95% CI, 0.75-1.17]). There were no significant differences between the 2 groups in any of the prespecified secondary end points. Barotrauma occurred in 30 of 159 patients (18.9%) in the helmet noninvasive ventilation group and 25 of 161 (15.5%) in the usual respiratory support group. Skin pressure injury occurred in 5 of 159 patients (3.1%) in the helmet noninvasive ventilation group and 10 of 161 (6.2%) in the usual respiratory support group. There were 2 serious adverse events in the helmet noninvasive ventilation group and 1 in the usual respiratory support group.

Conclusions and relevance: Results of this study suggest that helmet noninvasive ventilation did not significantly reduce 28-day mortality compared with usual respiratory support among patients with acute hypoxemic respiratory failure due to COVID-19 pneumonia. However, interpretation of the findings is limited by imprecision in the effect estimate, which does not exclude potentially clinically important benefit or harm.

Trial registration: ClinicalTrials.gov Identifier: NCT04477668.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Al-Dorzi reported receiving honoraria for educational activities from Sanofi outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Screening, Randomization, and Participant Flow in the Helmet-COVID Randomized Clinical Trial
Fio2 indicates fraction of inspired oxygen. Randomization was stratified according to site.
Figure 2.
Figure 2.. Kaplan-Meier Time-to-Event Curves for Mortality and Endotracheal Intubation in the Helmet Noninvasive Ventilation and Usual Respiratory Support Groups
All patients were observed to event or 28 days.
See this image and copyright information in PMC

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