Effect of Helmet Noninvasive Ventilation vs Usual Respiratory Support on Mortality Among Patients With Acute Hypoxemic Respiratory Failure Due to COVID-19
Author:
Arabi Yaseen M.123, Aldekhyl Sara123, Al Qahtani Saad123, Al-Dorzi Hasan M.123, Abdukahil Sheryl Ann123, Al Harbi Mohammed Khulaif234, Al Qasim Eman123, Kharaba Ayman5, Albrahim Talal6, Alshahrani Mohammed S.7, Al-Fares Abdulrahman A.8, Al Bshabshe Ali9, Mady Ahmed1011, Al Duhailib Zainab12, Algethamy Haifa13, Jose Jesna1314, Al Mutairi Mohammed2315, Al Zumai Omar2315, Al Haji Hussain2315, Alaqeily Ahmed2315, Al Aseri Zohair16, Al-Omari Awad17, Al-Dawood Abdulaziz123, Tlayjeh Haytham123, Al Obaidi Mohammad18, Al Baseet Faisal18, Al Fares Omar18, Al Suayb Abdullah18, Ismaiel Yassin18, Al Khalid Rami18, Sammanoudi Hashem18, Tabhan Edgardo18, Sadat Musharaf18, Al Wehaibi Wedyan18, Afesh Lara18, Bin Humaid Felwa18, Burrows Victoria18, Matroud Amal18, Naidu Brintha18, Hussien Mohamed18, AlFar Ahmad18, Al Asiri Salman18, Al Solami Anas18, Perlas Asonto Laila18, Mapusao Charlene18, Muthu Arivukodhi18, AlGhamdi Abdulaziz Saad18, Angala Carmelo18, Aldammad Munir Mustafa18, Alwadai Nasser M18, Palanivel Om Prakash18, Aldosari Naif Abdulrahman18, Alreyes Khalid Abdullah18, Lakshmanan Arul Prasath18, Al Obaed Alzahra18, Almushhen Mobarak18, Hali Fhausia18, Fibriantini Ika18, Marasigan Bobby Rose18, Baguisa Katrina18, Abu Riash Mahmoud18, Alotaimeen Haya18, Huma Rozeena18, Almahwi Saleh Ali18, Lugue Sheryl S18, Khan Liyakhat18, Gabr Moataz18, Baaziz Saleh18, Nuzhat Shehla18, Almumin Ahmed18, Alhaj Fahad18, Albert James18, Khan Israr18, Ayaz Muhammad18, Chalabi Jamal18, Al-Hameed Fahad18, Bin Eshaq Abdulhadi18, Alqahtani Rakan18, Alnafel Omar18,
Affiliation:
1. Intensive Care Department, Ministry of National Guard Health Affairs, Riyadh, Kingdom of Saudi Arabia 2. King Abdullah International Medical Research Center, Riyadh, Kingdom of Saudi Arabia 3. King Saud bin Abdulaziz University for Health Sciences, Riyadh, Kingdom of Saudi Arabia 4. Department of Anesthesia, Ministry of National Guard Health Affairs, Riyadh, Kingdom of Saudi Arabia 5. Pulmonary and Critical Care Departments, King Fahad Hospital, Madinah, Kingdom of Saudi Arabia 6. Department of Critical Care, King Fahad Hospital of the University, Imam Abdulrahman Bin Faisal University, Al Khobar, Kingdom of Saudi Arabia 7. Department of Emergency and Critical Care, King Fahad Hospital of the University, Imam Abdulrahman Bin Faisal University, Al Khobar, Kingdom of Saudi Arabia 8. Department of Anesthesia, Critical Care Medicine and Pain Medicine, Al-Amiri Hospital, Ministry of Health, Kuwait, Kuwait 9. Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha, Kingdom of Saudi Arabia 10. Intensive Care Department, King Saud Medical City, Riyadh, Kingdom of Saudi Arabia 11. College of Medicine, Tanta University, Tanta, Egypt 12. Adult Critical Care Medicine Department, King Faisal Specialist Hospital and Research Centre, Riyadh, Kingdom of Saudi Arabia 13. Department of Anesthesia and Critical Care, King Abdulaziz University, King Abdulaziz University Hospital, Jeddah, Kingdom of Saudi Arabia 14. Department of Bioinformatics and Biostatistics, King Abdullah International Medical Research Center, Riyadh, Kingdom of Saudi Arabia 15. Respiratory Services Department, Ministry of National Guard Health Affairs, Riyadh, Kingdom of Saudi Arabia 16. Emergency and Intensive Care Departments, College of Medicine, King Saud University, Riyadh, Kingdom of Saudi Arabia 17. Alfaisal University, Critical Care and Infectious Disease and Infection Control Departments, Dr Sulaiman Al Habib Medical Group, Riyadh, Kingdom of Saudi Arabia 18. for the Saudi Critical Care Trials Group
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
Publisher
American Medical Association (AMA)
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