• Intensive care medicine · Mar 2023

    Randomized Controlled Trial Multicenter Study

    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.

    • Yaseen M Arabi, Hasan M Al-Dorzi, Sara Aldekhyl, Saad Al Qahtani, Sheryl Ann Abdukahil, Al QasimEmanEIntensive Care Department, Ministry of the National Guard-Health Affairs, ICU 1425, PO Box 22490, Riyadh, 11426, Kingdom of Saudi Arabia.King Abdullah International Medical Research Center, Riyadh, Kingdom of Saudi Arabia.College of Medicine,, Mohammad Khulaif Al Harbi, Ayman Kharaba, Talal Albrahim, Mohammed S Alshahrani, Abdulrahman A Al-Fares, Ali Al Bshabshe, Ahmed Mady, Zainab Al Duhailib, Haifa Algethamy, Jesna Jose, Mohammed Al Mutairi, Omar Al Zumai, Hussain Al Haji, Ahmed Alaqeily, Wedyan Al Wehaibi, Zohair Al Aseri, Awad Al-Omari, Haytham Tlayjeh, Abdulaziz Al-Dawood, and Saudi Critical Care Trials Group.
    • Intensive Care Department, Ministry of the National Guard-Health Affairs, ICU 1425, PO Box 22490, Riyadh, 11426, Kingdom of Saudi Arabia. yaseenarabi@yahoo.com.
    • Intensive Care Med. 2023 Mar 1; 49 (3): 302312302-312.

    PurposeTo 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.MethodsThis 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.ResultsWithin 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).ConclusionsHelmet 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.© 2023. Springer-Verlag GmbH Germany, part of Springer Nature.

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