Helmet Non-Invasive Ventilation for COVID-19 Patients (Helmet-COVID): study protocol for a multicentre randomised controlled trial
Introduction Non-invasive ventilation (NIV) delivered by helmet has been used for respiratory support of patients with acute hypoxaemic respiratory failure due to COVID-19 pneumonia. The aim of this study was to compare helmet NIV with usual care versus usual care alone to reduce mortality.Methods a...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2021-08-01
|
| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/11/8/e052169.full |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1850136793425379328 |
|---|---|
| author | Yaseen M Arabi Khalid Alghamdi Eman Al Qasim Fahad Al-Hameed Haytham Tlayjeh Mohammed Almaani Zohair Al aseri Sara Aldekhyl Hasan M Al-Dorzi Sheryl Ann Abdukahil Mohammad Khulaif Al Harbi Husain Al Haji Mohammed Al Mutairi Omar Al Zumai Wedyan Al Wehaibi Saad Al Qahtani Jamal Chalabi Mohammed Alshahrani Talal Albrahim Abdulrahman Alharthy Ahmed Mady Abdulhadi Bin Eshaq Ali A Al bshabshe Zainab Al Duhailib Ayman Kharaba Rakan Alqahtani Adnan Al Ghamdi Ali Altalag Haifa Algethamy Ahmad Al Aqeily Faisal Al Baseet Hashem Al Samannoudi Mohammed Al Obaidi Yassin T Ismaiel Abdulrahman A Al-Fares |
| author_facet | Yaseen M Arabi Khalid Alghamdi Eman Al Qasim Fahad Al-Hameed Haytham Tlayjeh Mohammed Almaani Zohair Al aseri Sara Aldekhyl Hasan M Al-Dorzi Sheryl Ann Abdukahil Mohammad Khulaif Al Harbi Husain Al Haji Mohammed Al Mutairi Omar Al Zumai Wedyan Al Wehaibi Saad Al Qahtani Jamal Chalabi Mohammed Alshahrani Talal Albrahim Abdulrahman Alharthy Ahmed Mady Abdulhadi Bin Eshaq Ali A Al bshabshe Zainab Al Duhailib Ayman Kharaba Rakan Alqahtani Adnan Al Ghamdi Ali Altalag Haifa Algethamy Ahmad Al Aqeily Faisal Al Baseet Hashem Al Samannoudi Mohammed Al Obaidi Yassin T Ismaiel Abdulrahman A Al-Fares |
| author_sort | Yaseen M Arabi |
| collection | DOAJ |
| description | Introduction Non-invasive ventilation (NIV) delivered by helmet has been used for respiratory support of patients with acute hypoxaemic respiratory failure due to COVID-19 pneumonia. The aim of this study was to compare helmet NIV with usual care versus usual care alone to reduce mortality.Methods and analysis This is a multicentre, pragmatic, parallel randomised controlled trial that compares helmet NIV with usual care to usual care alone in a 1:1 ratio. A total of 320 patients will be enrolled in this study. The primary outcome is 28-day all-cause mortality. The primary outcome will be compared between the two study groups in the intention-to-treat and per-protocol cohorts. An interim analysis will be conducted for both safety and effectiveness.Ethics and dissemination Approvals are obtained from the institutional review boards of each participating institution. Our findings will be published in peer-reviewed journals and presented at relevant conferences and meetings.Trial registration number NCT04477668. |
| format | Article |
| id | doaj-art-4d65b23820e1441ca8076e70005693eb |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2021-08-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-4d65b23820e1441ca8076e70005693eb2025-08-20T02:31:02ZengBMJ Publishing GroupBMJ Open2044-60552021-08-0111810.1136/bmjopen-2021-052169Helmet Non-Invasive Ventilation for COVID-19 Patients (Helmet-COVID): study protocol for a multicentre randomised controlled trialYaseen M Arabi0Khalid Alghamdi1Eman Al Qasim2Fahad Al-Hameed3Haytham Tlayjeh4Mohammed Almaani5Zohair Al aseri6Sara Aldekhyl7Hasan M Al-Dorzi8Sheryl Ann Abdukahil9Mohammad Khulaif Al Harbi10Husain Al Haji11Mohammed Al Mutairi12Omar Al Zumai13Wedyan Al Wehaibi14Saad Al Qahtani15Jamal Chalabi16Mohammed Alshahrani17Talal Albrahim18Abdulrahman Alharthy19Ahmed Mady20Abdulhadi Bin Eshaq21Ali A Al bshabshe22Zainab Al Duhailib23Ayman Kharaba24Rakan Alqahtani25Adnan Al Ghamdi26Ali Altalag27Haifa Algethamy28Ahmad Al Aqeily29Faisal Al Baseet30Hashem Al Samannoudi31Mohammed Al Obaidi32Yassin T Ismaiel33Abdulrahman A Al-Fares34College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi ArabiaIntensive Care Department, King Faisal Specialist Hospital and Research Centre, Jeddah, Saudi ArabiaIntensive Care Department, Ministry of National Guard Health Affairs, Riyadh, Saudi ArabiaIntensive Care Department, Ministry of National Guard Health Affairs, Jeddah, Saudi ArabiaIntensive Care Department, Ministry of National Guard Health Affairs, Riyadh, Saudi ArabiaDepartment of Pulmonary and Critical Care Medicine, King Fahad Medical City, Riyadh, Saudi ArabiaDepartments of Emergency Medicine and Critical Care, College of Medicine, King Saud University, Riyadh, Saudi ArabiaIntensive Care Department, Ministry of National Guard Health Affairs, Riyadh, Saudi ArabiaIntensive Care Department, Ministry of National Guard Health Affairs, Riyadh, Saudi ArabiaIntensive Care Department, Ministry of National Guard Health Affairs, Riyadh, Saudi ArabiaCollege of Medicine, King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi ArabiaRespiratory Services Department, Ministry of National Guard Health Affairs, Riyadh, Saudi ArabiaRespiratory Services Department, Ministry of National Guard Health Affairs, Riyadh, Saudi ArabiaRespiratory Services Department, Ministry of National Guard Health Affairs, Riyadh, Saudi ArabiaIntensive Care Department, Ministry of National Guard Health Affairs, Riyadh, Saudi ArabiaIntensive Care Department, Ministry of National Guard Health Affairs, Riyadh, Saudi ArabiaIntensive Care Department, Ministry of National Guard Health Affairs, Al Ahsa, Saudi Arabiaprofessor of critical care and emergency medicineDepartment of Critical Care, Imam Abdulrahman Bin Faisal University, King Fahad Hospital of the University, Al Khobar, Saudi ArabiaIntensive Care Department, King Saud Medical City, Riyadh, Saudi ArabiaIntensive Care Department, King Saud Medical City, Riyadh, Saudi ArabiaIntensive Care Department, King Khalid Hospital Najran, Najran, Saudi ArabiaIntensive Care Department, Aseer Central Hospital, Abha, Saudi Arabiaconsultant intensivistPulmonary and Critical Care Departments, King Fahad Hospital Madinah, Madinah, Saudi ArabiaDepartment of Critical Care Medicine, College of Medicine, King Saud University, Riyadh, Saudi ArabiaDepartment of Intensive Care Services, Prince Sultan Military Medical City, Riyadh, Saudi ArabiaDepartment of Intensive Care Services, Prince Sultan Military Medical City, Riyadh, Saudi ArabiaDepartment of Anesthesia and Critical Care, King Abdulaziz University Hospital, Jeddah, Saudi ArabiaRespiratory Services Department, Ministry of National Guard Health Affairs, Riyadh, Saudi ArabiaRespiratory Services Department, Ministry of National Guard Health Affairs, Riyadh, Saudi ArabiaRespiratory Services Department, Ministry of National Guard Health Affairs, Riyadh, Saudi ArabiaRespiratory Services Department, Ministry of National Guard Health Affairs, Riyadh, Saudi ArabiaRespiratory Services Department, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia17 Departments of Anesthesia, Critical Care Medicine and Pain Medicine, Al-Amiri Hospital, Kuwait City, KuwaitIntroduction Non-invasive ventilation (NIV) delivered by helmet has been used for respiratory support of patients with acute hypoxaemic respiratory failure due to COVID-19 pneumonia. The aim of this study was to compare helmet NIV with usual care versus usual care alone to reduce mortality.Methods and analysis This is a multicentre, pragmatic, parallel randomised controlled trial that compares helmet NIV with usual care to usual care alone in a 1:1 ratio. A total of 320 patients will be enrolled in this study. The primary outcome is 28-day all-cause mortality. The primary outcome will be compared between the two study groups in the intention-to-treat and per-protocol cohorts. An interim analysis will be conducted for both safety and effectiveness.Ethics and dissemination Approvals are obtained from the institutional review boards of each participating institution. Our findings will be published in peer-reviewed journals and presented at relevant conferences and meetings.Trial registration number NCT04477668.https://bmjopen.bmj.com/content/11/8/e052169.full |
| spellingShingle | Yaseen M Arabi Khalid Alghamdi Eman Al Qasim Fahad Al-Hameed Haytham Tlayjeh Mohammed Almaani Zohair Al aseri Sara Aldekhyl Hasan M Al-Dorzi Sheryl Ann Abdukahil Mohammad Khulaif Al Harbi Husain Al Haji Mohammed Al Mutairi Omar Al Zumai Wedyan Al Wehaibi Saad Al Qahtani Jamal Chalabi Mohammed Alshahrani Talal Albrahim Abdulrahman Alharthy Ahmed Mady Abdulhadi Bin Eshaq Ali A Al bshabshe Zainab Al Duhailib Ayman Kharaba Rakan Alqahtani Adnan Al Ghamdi Ali Altalag Haifa Algethamy Ahmad Al Aqeily Faisal Al Baseet Hashem Al Samannoudi Mohammed Al Obaidi Yassin T Ismaiel Abdulrahman A Al-Fares Helmet Non-Invasive Ventilation for COVID-19 Patients (Helmet-COVID): study protocol for a multicentre randomised controlled trial BMJ Open |
| title | Helmet Non-Invasive Ventilation for COVID-19 Patients (Helmet-COVID): study protocol for a multicentre randomised controlled trial |
| title_full | Helmet Non-Invasive Ventilation for COVID-19 Patients (Helmet-COVID): study protocol for a multicentre randomised controlled trial |
| title_fullStr | Helmet Non-Invasive Ventilation for COVID-19 Patients (Helmet-COVID): study protocol for a multicentre randomised controlled trial |
| title_full_unstemmed | Helmet Non-Invasive Ventilation for COVID-19 Patients (Helmet-COVID): study protocol for a multicentre randomised controlled trial |
| title_short | Helmet Non-Invasive Ventilation for COVID-19 Patients (Helmet-COVID): study protocol for a multicentre randomised controlled trial |
| title_sort | helmet non invasive ventilation for covid 19 patients helmet covid study protocol for a multicentre randomised controlled trial |
| url | https://bmjopen.bmj.com/content/11/8/e052169.full |
| work_keys_str_mv | AT yaseenmarabi helmetnoninvasiveventilationforcovid19patientshelmetcovidstudyprotocolforamulticentrerandomisedcontrolledtrial AT khalidalghamdi helmetnoninvasiveventilationforcovid19patientshelmetcovidstudyprotocolforamulticentrerandomisedcontrolledtrial AT emanalqasim helmetnoninvasiveventilationforcovid19patientshelmetcovidstudyprotocolforamulticentrerandomisedcontrolledtrial AT fahadalhameed helmetnoninvasiveventilationforcovid19patientshelmetcovidstudyprotocolforamulticentrerandomisedcontrolledtrial AT haythamtlayjeh helmetnoninvasiveventilationforcovid19patientshelmetcovidstudyprotocolforamulticentrerandomisedcontrolledtrial AT mohammedalmaani helmetnoninvasiveventilationforcovid19patientshelmetcovidstudyprotocolforamulticentrerandomisedcontrolledtrial AT zohairalaseri helmetnoninvasiveventilationforcovid19patientshelmetcovidstudyprotocolforamulticentrerandomisedcontrolledtrial AT saraaldekhyl helmetnoninvasiveventilationforcovid19patientshelmetcovidstudyprotocolforamulticentrerandomisedcontrolledtrial AT hasanmaldorzi helmetnoninvasiveventilationforcovid19patientshelmetcovidstudyprotocolforamulticentrerandomisedcontrolledtrial AT sherylannabdukahil helmetnoninvasiveventilationforcovid19patientshelmetcovidstudyprotocolforamulticentrerandomisedcontrolledtrial AT mohammadkhulaifalharbi helmetnoninvasiveventilationforcovid19patientshelmetcovidstudyprotocolforamulticentrerandomisedcontrolledtrial AT husainalhaji helmetnoninvasiveventilationforcovid19patientshelmetcovidstudyprotocolforamulticentrerandomisedcontrolledtrial AT mohammedalmutairi helmetnoninvasiveventilationforcovid19patientshelmetcovidstudyprotocolforamulticentrerandomisedcontrolledtrial AT omaralzumai helmetnoninvasiveventilationforcovid19patientshelmetcovidstudyprotocolforamulticentrerandomisedcontrolledtrial AT wedyanalwehaibi helmetnoninvasiveventilationforcovid19patientshelmetcovidstudyprotocolforamulticentrerandomisedcontrolledtrial AT saadalqahtani helmetnoninvasiveventilationforcovid19patientshelmetcovidstudyprotocolforamulticentrerandomisedcontrolledtrial AT jamalchalabi helmetnoninvasiveventilationforcovid19patientshelmetcovidstudyprotocolforamulticentrerandomisedcontrolledtrial AT mohammedalshahrani helmetnoninvasiveventilationforcovid19patientshelmetcovidstudyprotocolforamulticentrerandomisedcontrolledtrial AT talalalbrahim helmetnoninvasiveventilationforcovid19patientshelmetcovidstudyprotocolforamulticentrerandomisedcontrolledtrial AT abdulrahmanalharthy helmetnoninvasiveventilationforcovid19patientshelmetcovidstudyprotocolforamulticentrerandomisedcontrolledtrial AT ahmedmady helmetnoninvasiveventilationforcovid19patientshelmetcovidstudyprotocolforamulticentrerandomisedcontrolledtrial AT abdulhadibineshaq helmetnoninvasiveventilationforcovid19patientshelmetcovidstudyprotocolforamulticentrerandomisedcontrolledtrial AT aliaalbshabshe helmetnoninvasiveventilationforcovid19patientshelmetcovidstudyprotocolforamulticentrerandomisedcontrolledtrial AT zainabalduhailib helmetnoninvasiveventilationforcovid19patientshelmetcovidstudyprotocolforamulticentrerandomisedcontrolledtrial AT aymankharaba helmetnoninvasiveventilationforcovid19patientshelmetcovidstudyprotocolforamulticentrerandomisedcontrolledtrial AT rakanalqahtani helmetnoninvasiveventilationforcovid19patientshelmetcovidstudyprotocolforamulticentrerandomisedcontrolledtrial AT adnanalghamdi helmetnoninvasiveventilationforcovid19patientshelmetcovidstudyprotocolforamulticentrerandomisedcontrolledtrial AT alialtalag helmetnoninvasiveventilationforcovid19patientshelmetcovidstudyprotocolforamulticentrerandomisedcontrolledtrial AT haifaalgethamy helmetnoninvasiveventilationforcovid19patientshelmetcovidstudyprotocolforamulticentrerandomisedcontrolledtrial AT ahmadalaqeily helmetnoninvasiveventilationforcovid19patientshelmetcovidstudyprotocolforamulticentrerandomisedcontrolledtrial AT faisalalbaseet helmetnoninvasiveventilationforcovid19patientshelmetcovidstudyprotocolforamulticentrerandomisedcontrolledtrial AT hashemalsamannoudi helmetnoninvasiveventilationforcovid19patientshelmetcovidstudyprotocolforamulticentrerandomisedcontrolledtrial AT mohammedalobaidi helmetnoninvasiveventilationforcovid19patientshelmetcovidstudyprotocolforamulticentrerandomisedcontrolledtrial AT yassintismaiel helmetnoninvasiveventilationforcovid19patientshelmetcovidstudyprotocolforamulticentrerandomisedcontrolledtrial AT abdulrahmanaalfares helmetnoninvasiveventilationforcovid19patientshelmetcovidstudyprotocolforamulticentrerandomisedcontrolledtrial |