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.

التفاصيل البيبلوغرافية
العنوان:	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.
المؤلفون:	Arabi YM; Intensive Care Department, Ministry of the National Guard-Health Affairs, ICU 1425, PO Box 22490, Riyadh, 11426, Kingdom of Saudi Arabia. yaseenarabi@yahoo.com.; King Abdullah International Medical Research Center, Riyadh, Kingdom of Saudi Arabia. yaseenarabi@yahoo.com.; College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Kingdom of Saudi Arabia. yaseenarabi@yahoo.com., Al-Dorzi HM; Intensive 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, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Kingdom of Saudi Arabia., Aldekhyl S; Intensive 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, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Kingdom of Saudi Arabia., Al Qahtani S; Intensive 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, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Kingdom of Saudi Arabia., Abdukahil SA; Intensive 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, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Kingdom of Saudi Arabia., Al Qasim E; Intensive 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, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Kingdom of Saudi Arabia., Al Harbi MK; King Abdullah International Medical Research Center, Riyadh, Kingdom of Saudi Arabia.; College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Kingdom of Saudi Arabia.; Department of Anesthesia, Ministry of the National Guard-Health Affairs, Riyadh, Kingdom of Saudi Arabia., Kharaba A; Pulmonary & Critical Care Departments, King Fahad Hospital, Madinah, Kingdom of Saudi Arabia., Albrahim T; Department of Emergency and Critical Care, King Fahad Hospital of the University, Imam Abdulrahman Bin Faisal University, Al Khobar, Kingdom of Saudi Arabia., Alshahrani MS; Department of Critical Care, King Fahad Hospital of the University, Imam Abdulrahman Bin Faisal University, Al Khobar, Kingdom of Saudi Arabia., Al-Fares AA; Department of Anesthesia, Critical Care Medicine and Pain Medicine, Al-Amiri Hospital, Ministry of Health, Kuwait, Kuwait., Al Bshabshe A; Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha, Kingdom of Saudi Arabia., Mady A; Intensive Care Department, King Saud Medical City, Riyadh, Kingdom of Saudi Arabia.; College of Medicine, Tanta, University, Tanta, Egypt., Al Duhailib Z; Critical Care Department, King Faisal Specialist Hospital & Research Centre, Riyadh, Kingdom of Saudi Arabia.; College of Medicine, Alfaisal University, Riyadh, Kingdom of Saudi Arabia., Algethamy H; Department of Anesthesia and Critical Care, King Abdulaziz University, King Abdulaziz University Hospital, Jeddah, Kingdom of Saudi Arabia., Jose J; Intensive Care Department, Ministry of the National Guard-Health Affairs, ICU 1425, PO Box 22490, Riyadh, 11426, Kingdom of Saudi Arabia.; College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Kingdom of Saudi Arabia.; Department of Bioinformatics and Biostatistics, King Abdullah International Medical Research Center, Riyadh, Kingdom of Saudi Arabia., Al Mutairi M; King Abdullah International Medical Research Center, Riyadh, Kingdom of Saudi Arabia.; College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Kingdom of Saudi Arabia.; Respiratory Services Department, Ministry of National Guard - Health Affairs, Riyadh, Kingdom of Saudi Arabia., Al Zumai O; King Abdullah International Medical Research Center, Riyadh, Kingdom of Saudi Arabia.; College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Kingdom of Saudi Arabia.; Respiratory Services Department, Ministry of National Guard - Health Affairs, Riyadh, Kingdom of Saudi Arabia., Al Haji H; King Abdullah International Medical Research Center, Riyadh, Kingdom of Saudi Arabia.; College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Kingdom of Saudi Arabia.; Respiratory Services Department, Ministry of National Guard - Health Affairs, Riyadh, Kingdom of Saudi Arabia., Alaqeily A; King Abdullah International Medical Research Center, Riyadh, Kingdom of Saudi Arabia.; College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Kingdom of Saudi Arabia.; Respiratory Services Department, Ministry of National Guard - Health Affairs, Riyadh, Kingdom of Saudi Arabia., Al Wehaibi W; Intensive 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, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Kingdom of Saudi Arabia., Al Aseri Z; Emergency and Intensive Care Departments, College of Medicine, King Saud University, Riyadh, Kingdom of Saudi Arabia., Al-Omari A; College of Medicine, Alfaisal University, Riyadh, Kingdom of Saudi Arabia.; Critical Care and Infectious Disease & Infection Control Departments, Dr. Sulaiman Al Habib Medical Group, Riyadh, Kingdom of Saudi Arabia., Tlayjeh H; Intensive 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, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Kingdom of Saudi Arabia., Al-Dawood A; Intensive 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, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Kingdom of Saudi Arabia.
مؤلفون مشاركون:	Saudi Critical Care Trials Group
المصدر:	Intensive care medicine [Intensive Care Med] 2023 Mar; Vol. 49 (3), pp. 302-312. Date of Electronic Publication: 2023 Feb 23.
نوع المنشور:	Randomized Controlled Trial; Multicenter Study; Journal Article
اللغة:	English
بيانات الدورية:	Publisher: Springer Verlag Country of Publication: United States NLM ID: 7704851 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1432-1238 (Electronic) Linking ISSN: 03424642 NLM ISO Abbreviation: Intensive Care Med Subsets: MEDLINE
أسماء مطبوعة:	Publication: New York : Springer Verlag Original Publication: Berlin ; New York, Springer International.
مواضيع طبية MeSH:	Noninvasive Ventilation* , COVID-19/therapy , Respiratory Insufficiency/etiology , Respiratory Insufficiency*/therapy, Adult ; Humans ; Follow-Up Studies ; Head Protective Devices ; Quality of Life
مستخلص:	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. (© 2023. Springer-Verlag GmbH Germany, part of Springer Nature.)
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معلومات مُعتمدة:	RC20/306/R King Abdullah International Medical Research Center
فهرسة مساهمة:	Investigator: YM Arabi; HM Al-Dorzi; H Tlayjeh; S Aldekhyl; S Al-Qahtani; MK Al-Harbi; M Al-Mutairi; H Al-Haji; O Al-Zumai; A Alaqeily; SA Abdukahil; E Al-Qasim; J Jose; YM Arabi; H Al-Dorzi; SA Abdukahil; N Hill; S Nava; J Mojica; M Harhay; A Al-Fares; A Almumin; J Albert; I Khan; M Ayaz; A Al Bshabshe; MM Aldammad; NM Alwadai; OP Palanivel; YM Arabi; HM Al-Dorzi; H Tlayjeh; M Al Harbi; S Aldekhyl; S Al Qahtani; A Al-Dawood; SAI Abdukahil; E Al Qasim; J Jose; W Al Wehaibi; M Sadat; L Afesh; F Bin Humaid; M Al Mutairi; H Al Haji; O Al Zumai; A Alaqeily; Y Ismaiel; F Al Baseet; M Al Obaidi; E Tabhan; R Al Khalid; O Al Fares; A Al Suayb; H Sammanoudi; V Burrows; A Matroud; B Naidu; H Algethamy; S Lungue; L Khan; M Jaber; S Baaziz; S Nuzhat; MS Alshahrani; TA Albrahim; LP Asonto; C Mapusao; A Muthu; AS AlGhamdi; C Angala; A Kharaba; M Hussien; A AlFar; S Al Asiri; A Al Solami; Z Al Duhailib; M Abu Riash; H Al Othaimeen; R Huma; A Mady; NA Aldosari; KA Alreyes; AP Lakshmanan; A Al Obaed; M Almushhen; F Hali; I Fibriantini; BR Marasigan; K Baguisa; SA Almahwi; J Chalabi; F Al-Hameed; A Bin Eshaq; R Alqahtani; O Alnafel; Z Al Aseri; A Al-Omari Keywords: Acute hypoxemic respiratory failure; COVID-19; Helmet; High-flow nasal oxygen; Noninvasive ventilation; Quality of life
سلسلة جزيئية:	ClinicalTrials.gov NCT04477668
تواريخ الأحداث:	Date Created: 20230223 Date Completed: 20230313 Latest Revision: 20230328
رمز التحديث:	20240628
مُعرف محوري في PubMed:	PMC9947895
DOI:	10.1007/s00134-023-06981-5
PMID:	36820878
قاعدة البيانات:	MEDLINE

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تدمد:	1432-1238
DOI:	10.1007/s00134-023-06981-5