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 stu...

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Detalles Bibliográficos
Autores principales: 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Berlin Heidelberg 2023
Materias:
Original
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9947895/
https://www.ncbi.nlm.nih.gov/pubmed/36820878
http://dx.doi.org/10.1007/s00134-023-06981-5
Descripción
Sumario: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. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s00134-023-06981-5.

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