What is the effect of noninvasive ventilation delivered by helmet compared with usual respiratory support (mask noninvasive ventilation, high-flow nasal oxygen, and standard oxygen) on the risk of mortality among adults with acute hypoxemic respiratory failure due to COVID-19?
In this randomized clinical trial that included 320 adults with acute hypoxemic respiratory failure related to COVID-19, randomization to helmet use compared with usual respiratory support resulted in mortality within 28 days in 27.0% vs 26.1%, respectively. This difference was not statistically significant.
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 size estimate.
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.
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.
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.
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.
ClinicalTrials.gov Identifier: NCT04477668
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CME Disclosure Statement: Unless noted, all individuals in control of content reported no relevant financial relationships. If applicable, all relevant financial relationships have been mitigated.
Corresponding Author: Yaseen M. Arabi, MD, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Intensive Care Department, Ministry of National Guard Health Affairs, ICU 1425, PO Box 22490, Riyadh 11426, Kingdom of Saudi Arabia (firstname.lastname@example.org).
Accepted for Publication: August 21, 2022.
Author Contributions: Dr Arabi had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Arabi, Al-Dorzi, Al Aseri, Al-Omari, Tlayjeh.
Acquisition, analysis, or interpretation of data: Arabi, Aldekhyl, Al-Qahtani, Al-Dorzi, Abdukahil, Al Harbi, Al Qasim, Kharaba, Albrahim, Alshahrani, Al-Fares, Al Bshabshe, Mady, Al Duhailib, Algethamy, Jose, Al Mutairi, Al Zumai, Al Haji, Alaqeily, Al Aseri, Al-Dawood, Tlayjeh.
Drafting of the manuscript: Arabi, Al-Dorzi, Abdukahil.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Arabi, Aldekhyl, Al-Qahtani, Abdukahil, Al Harbi, Al Qasim, Al Duhailib, Jose, Al Mutairi, Al Zumai, Alaqeily, Al Aseri, Al-Dawood, Tlayjeh.
Obtained funding: Arabi.
Administrative, technical, or material support: All authors.
Supervision: Arabi, Aldekhyl, Al-Qahtani, Abdukahil, Al Harbi, Al Qasim, Kharaba, Albrahim, Al-Fares, Jose, Al Mutairi, Al Zumai, Al Haji, Alaqeily, Al-Omari, Al-Dawood, Tlayjeh.
Conflict of Interest Disclosures: Dr Al-Dorzi reported receiving honoraria for educational activities from Sanofi outside the submitted work. No other disclosures were reported.
Funding/Support: The trial was funded by King Abdullah International Medical Research Center (grant RC20/306R), Riyadh, Saudi Arabia.
Role of the Funder/Sponsor: The study funder provided support for research coordination, statistical support, and monitoring but had no role in the design of the study; data collection, study management, and interpretation of the data; preparation, review, or approval of the manuscript; or decision to submit the manuscript for publication.
Collaborators: Members of the Saudi Critical Care Trials Group are listed in Supplement 3.
Data Sharing Statement: See Supplement 4.
Additional Contributions: We would like to thank all the participating patients and their families, as well as the members of the data and safety monitoring board (DSMB): Nicholas S. Hill, MD, chair (Tufts Medical Center, Boston, Massachusetts), Stefano Nava, MD (Alma Mater Studiorum University of Bologna, IRCCS Sant’Orsola Hospital, and Respiratory and Critical Care Unit, University of Bologna, Italy), James Mojica, MD (Division of Pulmonary and Critical Care Medicine, Massachusetts General Hospital), and Michael Harhay, PhD (Epidemiology and Medicine–Pulmonary and Critical Care, Department of Biostatistics, Epidemiology and Informatics, University of Pennsylvania). The DSMB members received honoraria for their roles.
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