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

Purpose To evaluate whether helmet noninvasive ventilation compared to usual respiratory support reduces 180-day mortality and improves health-related quality of life (HRQoL) in patients with acute hypoxemic respiratory failure due to COVID-19 pneumonia. Methods This is a pre-planned follow-up study...

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Published in:Intensive care medicine 2023-03, Vol.49 (3), p.302-312
Main Authors: Arabi, Yaseen M., Al-Dorzi, Hasan M., Aldekhyl, Sara, Al Qahtani, Saad, Abdukahil, Sheryl Ann, Al Qasim, Eman, Al Harbi, Mohammad Khulaif, 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 Wehaibi, Wedyan, Al Aseri, Zohair, Al-Omari, Awad, Tlayjeh, Haytham, Al-Dawood, Abdulaziz
Format: Article
Language:English
Subjects:
Adult
Anesthesiology
Clinical outcomes
Clinical trials
Comparative analysis
Confidence intervals
Coronaviruses
COVID-19
COVID-19 - therapy
Critical Care Medicine
Dexmedetomidine
Emergency Medicine
Failure
Follow-Up Studies
Head Protective Devices
Helmets
Humans
Intensive
Mechanical ventilation
Medicine
Medicine & Public Health
Mortality
NCT
NCT04477668
Noninvasive Ventilation
Original
Oxygen therapy
Pain Medicine
Pediatrics
Pneumology/Respiratory System
Pneumonia
Product development
Protective equipment
Quality of Life
Respiratory failure
Respiratory Insufficiency - etiology
Respiratory Insufficiency - therapy
Saudi Arabia
Severe acute respiratory syndrome coronavirus 2
United Kingdom
Ventilation
Viral diseases
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Summary:Purpose To evaluate whether helmet noninvasive ventilation compared to usual respiratory support reduces 180-day mortality and improves health-related quality of life (HRQoL) in patients with acute hypoxemic respiratory failure due to COVID-19 pneumonia. Methods This is a pre-planned follow-up study of the Helmet-COVID trial. In this multicenter, randomized clinical trial, adults with acute hypoxemic respiratory failure ( n  = 320) due to coronavirus disease 2019 (COVID-19) were randomized to receive helmet noninvasive ventilation or usual respiratory support. The modified intention-to-treat population consisted of all enrolled patients except three who were lost at follow-up. The study outcomes were 180-day mortality, EuroQoL (EQ)-5D-5L index values, and EQ-visual analog scale (EQ-VAS). In the modified intention-to-treat analysis, non-survivors were assigned a value of 0 for EQ-5D-5L and EQ-VAS. Results Within 180 days, 63/159 patients (39.6%) died in the helmet noninvasive ventilation group compared to 65/158 patients (41.1%) in the usual respiratory support group (risk difference − 1.5% (95% confidence interval [CI] − 12.3, 9.3, p  = 0.78). In the modified intention-to-treat analysis, patients in the helmet noninvasive ventilation and the usual respiratory support groups did not differ in EQ-5D-5L index values (median 0.68 [IQR 0.00, 1.00], compared to 0.67 [IQR 0.00, 1.00], median difference 0.00 [95% CI − 0.32, 0.32; p  = 0.91]) or EQ-VAS scores (median 70 [IQR 0, 93], compared to 70 [IQR 0, 90], median difference 0.00 (95% CI − 31.92, 31.92; p  = 0.55). Conclusions Helmet noninvasive ventilation did not reduce 180-day mortality or improve HRQoL compared to usual respiratory support among patients with acute hypoxemic respiratory failure due to COVID-19 pneumonia.
ISSN:0342-4642
1432-1238
DOI:10.1007/s00134-023-06981-5