Statistical Analysis Plan for the Helmet Non-Invasive Ventilation for COVID-19 Patients (Helmet-COVID) Randomized Controlled Trial
Statistical Analysis Plan for the Helmet Non-Invasive Ventilation for COVID-19 Patients (Helmet-COVID) Randomized Controlled Trial
Abstract Background and objectiveNoninvasive respiratory support is frequently needed for patients with acute hypoxemic respiratory failure due to coronavirus disease 19 (COVID-19). Helmet noninvasive ventilation having multiple advantages over other support modalities but data about effectiveness are limited. MethodsIn this multicenter randomized trial of helmet non-invasive ventilation for COVID-19 patients (Helmet-COVID), 320 adult ICU patients with suspected or confirmed COVID-19 and acute hypoxemic respiratory failure (with a ratio of arterial oxygen partial pressure to fraction (percent) of inspired oxygen (PaO2/FiO2) <200 despite supplemental oxygen with a partial/non-rebreathing mask at a flow rate >10 L/min or above) will be randomized to helmet-noninvasive ventilation with usual care or usual care alone. The primary outcome is death from any cause within 28 days after randomization. The trial has 80% power to detect a 15% absolute risk reduction from 40% to 25%. ConclusionConsistent with international guidelines, we developed a detailed plan to guide the analysis of the Helmet-COVID trial. This plan specifies the statistical methods for the evaluation of primary and secondary outcomes to facilitate unbiased analyses of clinical data. Trial registrationClinicaltrials.gov: NCT04477668 (registered on July 20, 2020)
Aldekhyl Sara、Al-Dorzi Hasan、Mady Ahmed、Duhailib Zainab Al、Alnafel Omar、Al-Fares Abdulrahman A、Abdukahil Sheryl Ann、Al Harbi Mohammad Khulaif、Zumai Omar Al、Wehaibi Wedyan Al、Haji Husain Al、Bshabshe Ali Al、Qahtani Saad Al、Alqahtani Rakan、Tlayjeh Haytham、Algethamy Haifa、Mutairi Mohammed Al、Aseri Zohair Al、Jose Jesna、Kharaba Ayman、Albrahim Talal、Alshahrani Mohammed、Arabi Yaseen、Qasim Eman Al、Alfaris Omar
College of Medicine, King Saud Bin Abdulaziz University for Health Sciences King Abdullah International Medical Research Center Ministry of National Guard Health AffairsIntensive Care Department, Ministry of National Guard Health Affairs King Abdullah International Medical Research Center King Saud Bin Abdulaziz University for Health SciencesIntensive Care Department King Saud Medical City Riyadh College of Medicine, Tanta UniversityAdult Critical Care Department King Faisal Specialist Hospital & Research Center RiyadhInternal Medicine and Intensive Care Department King Salman Specialist HospitalDepartment of Anesthesia, Critical Care Medicine and Pain Medicine Al-Amiri Hospital, Ministry of HealthIntensive Care Department, Ministry of National Guard Health Affairs King Abdullah International Medical Research Center King Saud Bin Abdulaziz University for Health SciencesDepartment of Anesthesia, Ministry of National Guard Health Affairs King Abdullah International Medical Research Center King Saud Bin Abdulaziz University for Health SciencesRespiratory Services Department, Ministry of National Guard Health Affairs King Abdullah International Medical Research Center King Saud Bin Abdulaziz University for Health SciencesIntensive Care Department, Ministry of National Guard Health Affairs King Abdullah International Medical Research Center King Saud Bin Abdulaziz University for Health SciencesRespiratory Services Department, Ministry of National Guard Health Affairs King Abdullah International Medical Research Center King Saud Bin Abdulaziz University for Health SciencesDepartment of Critical Care Medicine King Khalid University, Aseer Central Hospital Abha, Kingdom of Saudi ArabiaIntensive Care Department, Ministry of National Guard Health Affairs King Abdullah International Medical Research Center King Saud Bin Abdulaziz University for Health SciencesDepartment of Critical Care, King Khalid University Hospital King Saud University Medical CityIntensive Care Department, Ministry of National Guard Health Affairs King Abdullah International Medical Research Center King Saud Bin Abdulaziz University for Health SciencesDepartment of Anesthesia King Abdulaziz University Hospital JeddahRespiratory Services Department, Ministry of National Guard Health Affairs King Abdullah International Medical Research Center King Saud Bin Abdulaziz University for Health SciencesEmergency and Intensive Care Departments College of Medicine King Saud University RiyadhBioinformatics and Biostatistics Department, King Abdullah International Medical Research Center King Saud Bin Abdulaziz University for Health Sciences Ministry of National Guard Health AffairsPulmonary & Critical Care Departments, King Fahad Hospital Madinah Critical Care Units- Madinah Region, Ministry of HealthDepartment of Critical Care King Fahad Hospital of the University Imam Abdulrahman Bin Faisal University Al Khobar, Kingdom of Saudi ArabiaDepartment of Emergency and Critical Care King Fahad Hospital of the University Imam Abdulrahman Bin Faisal University Al Khobar, Kingdom of Saudi ArabiaIntensive Care Department, Ministry of National Guard Health Affairs King Abdullah International Medical Research Center King Saud Bin Abdulaziz University for Health SciencesResearch Office, King Abdullah International Medical Research Center King Saud Bin Abdulaziz University for Health Sciences Ministry of National Guard Health AffairsRespiratory Services Department, Ministry of National Guard Health Affairs King Abdullah International Medical Research Center King Saud Bin Abdulaziz University for Health Sciences
医学研究方法临床医学内科学
Aldekhyl Sara,Al-Dorzi Hasan,Mady Ahmed,Duhailib Zainab Al,Alnafel Omar,Al-Fares Abdulrahman A,Abdukahil Sheryl Ann,Al Harbi Mohammad Khulaif,Zumai Omar Al,Wehaibi Wedyan Al,Haji Husain Al,Bshabshe Ali Al,Qahtani Saad Al,Alqahtani Rakan,Tlayjeh Haytham,Algethamy Haifa,Mutairi Mohammed Al,Aseri Zohair Al,Jose Jesna,Kharaba Ayman,Albrahim Talal,Alshahrani Mohammed,Arabi Yaseen,Qasim Eman Al,Alfaris Omar.Statistical Analysis Plan for the Helmet Non-Invasive Ventilation for COVID-19 Patients (Helmet-COVID) Randomized Controlled Trial[EB/OL].(2025-03-28)[2025-04-30].https://www.medrxiv.org/content/10.1101/2021.07.26.21260421.点此复制
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