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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

2023; Springer Science+Business Media; Volume: 49; Issue: 3 Linguagem: Inglês

10.1007/s00134-023-06981-5

1432-1238

Yaseen M. Arabi, Hasan M. Al‐Dorzi, Sara Aldekhyl, Saad Al Qahtani, Sheryl Ann Abdukahil, Eman Al Qasim, Mohammad Khulaif Al Harbi, Ayman Kharaba, Talal Albrahim, Mohammed Alshahrani, Abdulrahman 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, Yaseen M. Arabi, Hasan M. Al‐Dorzi, Haytham Tlayjeh, Sara Aldekhyl, Saad Al-Qahtani, Mohammed Khulaif Alharbi, Mohammad Almutairi, Hussain Al-Haji, Omar A. Alzumai -, Ahmed Alaqeily, Sheryl Ann Abdukahil, Eman Al-Qasim, Jesna Jose, Yaseen M. Arabi, Hasan M. Al‐Dorzi, Sheryl Ann Abdukahil, Nicholas S. Hill, Stefano Nava, James Mojica, Michael O. Harhay, Abdulrahman Al‐Fares, Ahmed Almumin, James S. Albert, Israr Khan, Muhammad Ayaz, Ali Al Bshabshe, Munir Mustafa Aldammad, Nasser M. Alwadai, Om Prakash Palanivel, Yaseen M. Arabi, Hasan M. Al‐Dorzi, Haytham Tlayjeh, Mohammad Al Harbi, Sara Aldekhyl, Saad Al Qahtani, Abdulaziz Al‐Dawood, Sheryl Ann Abdukahil, Eman Al Qasim, Jesna Jose, Wedyan Al Wehaibi, Musharaf Sadat, Lara Afesh, Felwa Bin Humaid, Mohammad Al Mutairi, Hussain Al Haji, Omar Al Zumai, Ahmed Alaqeily, Yassin Ismaiel, Faisal Al Baseet, Mohammad Al Obaidi, Edgardo Tabhan, Ali Al Bshabshe, Omar Al Fares, Abdullah Al Suayb, Hashem Sammanoudi, Victoria Burrows, Amal Matroud, Brintha Naidu, Haifa Algethamy, Sheryl Lungue, Liyakat Khan, Moataz Jaber, Saleh T. Baaziz, Nuzhat Shehla, Mohammed Alshahrani, Talal Albrahim, Laila Perlas Asonto, Charlene Mapusao, Arivukodhi Muthu, Abdulaziz Saad AlGhamdi, Carmelo Angala, Ayman Kharaba, Mohamed Hussien, Ahmad AlFar, Salman Al Asiri, Anas Al Solami, Zainab Al Duhailib, Mahmoud Abu Riash, Haya Al Othaimeen, Rozeena Huma, Ahmed Mady, Naif Abdulrahman Aldosari, Khalid Abdullah Alreyes, Arul Prasath Lakshmanan, Alzahra Al Obaed, Mobarak Almushhen, Fhausia Hali, Ika Fibriantini, Bobby Rose Marasigan, Katrina Baguisa, Saleh Ali Almahwi, Jamal Chalabi, Fahad Al-Hameed, Abdulhadi Bin Eshaq, Rakan Alqahtani, Omar Alnafel, Zohair Al Aseri, Awad Al‐Omari,

Respiratory Support and Mechanisms

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. 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. 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). 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.