Effect of Helmet Noninvasive Ventilation vs Usual Respiratory Support on Mortality Among Patients With Acute Hypoxemic Respiratory Failure Due to COVID-19

Abstract

ImportanceHelmet 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.ObjectiveTo 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 ParticipantsThis 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.InterventionsPatients 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 MeasuresThe 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.ResultsAmong 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 RelevanceResults 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 RegistrationClinicalTrials.gov Identifier: NCT04477668

Authors` response to “Efficacy of noninvasive ventilation in patients with COVID-19”

“…We believe that the relatively high NIV failure rate in our study is multifactorial. First, participants in our study were significantly older than the sample enrolled by Arabi and colleagues (76 vs 58 years) in a study cited by the authors [ 2 ]. Despite not having collected granular data on pre-ICU respiratory support, we agree that many patients with severe COVID-19-related respiratory failure received high-flow nasal oxygen therapy or NIV outside of ICUs, potentially leading to a delay of intubation and worse outcomes.…”

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 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.…”

Fokus Beatmung, Sauerstofftherapie und Weaning 2021/2022

“…Arabi YM, Aldekhyl S, Al Qahtani S et al (2022) 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. JAMA 328(11):1063–1072 [ 13 ]…”

“…Das Ziel der Studie von Arabi et al. war es daher, zu untersuchen, ob die nichtinvasive Beatmung mit Helm im Vergleich zur üblichen Atemunterstützung die 28-Tage-Gesamtmortalität bei Patienten mit akutem hypoxämischem Atemversagen aufgrund von COVID-19 verringern würde [ 13 ]. Es handelte sich um eine multizentrische, pragmatische, randomisierte klinische Studie, die zwischen dem 08.02.2021 und dem 16.11.2021 an 8 Standorten in Saudi-Arabien und Kuwait durchgeführt wurde.…”