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- Title
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.
- 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
- Abstract
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.
- Subjects
NONINVASIVE ventilation; COVID-19; QUALITY of life; HELMETS; CORONAVIRUS diseases; CLINICAL trials; SUPPORT groups
- Publication
Intensive Care Medicine, 2023, Vol 49, Issue 3, p302
- ISSN
0342-4642
- Publication type
Article
- DOI
10.1007/s00134-023-06981-5