Effect of Helmet Noninvasive Ventilation vs Usual Respiratory Support on Mortality Among Patients With Acute Hypoxemic Respiratory Failure Due to COVID-19
Authors: Arabi Yaseen M. , Aldekhyl Sara , Al Qahtani Saad , Al-Dorzi Hasan M. , Abdukahil Sheryl Ann , Al Harbi Mohammed Khulaif , Al Qasim Eman , Kharaba Ayman , Albrahim Talal , Alshahrani Mohammed S. , Al-Fares Abdulrahman A. , Al Bshabshe Ali , Mady Ahmed , Al Duhailib Zainab , Algethamy Haifa , Jose Jesna , Al Mutairi Mohammed , Al Zumai Omar , Al Haji Hussain , Alaqeily Ahmed , Al Aseri Zohair , Al-Omari Awad , Al-Dawood Abdulaziz , Tlayjeh Haytham ,   Saudi Critical Care Trials Group, Al Obaidi Mohammad , Al Baseet Faisal , Al Fares Omar , Al Suayb Abdullah , Ismaiel Yassin , Al Khalid Rami , Sammanoudi Hashem , Tabhan Edgardo , Sadat Musharaf , Al Wehaibi Wedyan , Afesh Lara , Bin Humaid Felwa , Burrows Victoria , Matroud Amal , Naidu Brintha , Hussien Mohamed , AlFar Ahmad , Al Asiri Salman , Al Solami Anas , Perlas Asonto Laila , Mapusao Charlene , Muthu Arivukodhi , AlGhamdi Abdulaziz Saad , Angala Carmelo , Aldammad Munir Mustafa , Alwadai Nasser M , Palanivel Om Prakash , Aldosari Naif Abdulrahman , Alreyes Khalid Abdullah , Lakshmanan Arul Prasath , Al Obaed Alzahra , Almushhen Mobarak , Hali Fhausia , Fibriantini Ika , Marasigan Bobby Rose , Baguisa Katrina , Abu Riash Mahmoud , Alotaimeen Haya , Huma Rozeena , Almahwi Saleh Ali , Lugue Sheryl S , Khan Liyakhat , Gabr Moataz , Baaziz Saleh , Nuzhat Shehla , Almumin Ahmed , Alhaj Fahad , Albert James , Khan Israr , Ayaz Muhammad , Chalabi Jamal , Al-Hameed Fahad , Bin Eshaq Abdulhadi , Alqahtani Rakan , Alnafel Omar 
Published: September 2022

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