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Helmet Non-Invasive Ventilation for COVID-19 Patients (Helmet-COVID): study protocol for a multicentre randomised controlled trial.
Arabi, Yaseen M; Tlayjeh, Haytham; Aldekhyl, Sara; Al-Dorzi, Hasan M; Abdukahil, Sheryl Ann; Al Harbi, Mohammad Khulaif; Al Haji, Husain; Al Mutairi, Mohammed; Al Zumai, Omar; Al Qasim, Eman; Al Wehaibi, Wedyan; Al Qahtani, Saad; Al-Hameed, Fahad; Chalabi, Jamal; Alshahrani, Mohammed; Albrahim, Talal; Alharthy, Abdulrahman; Mady, Ahmed; Bin Eshaq, Abdulhadi; Al Bshabshe, Ali A; Al Aseri, Zohair; Al Duhailib, Zainab; Kharaba, Ayman; Alqahtani, Rakan; Al Ghamdi, Adnan; Altalag, Ali; Alghamdi, Khalid; Almaani, Mohammed; Algethamy, Haifa; Al Aqeily, Ahmad; Al Baseet, Faisal; Al Samannoudi, Hashem; Al Obaidi, Mohammed; Ismaiel, Yassin T; Al-Fares, Abdulrahman A.
  • Arabi YM; Intensive Care Department, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia yaseenarabi@yahoo.com.
  • Tlayjeh H; College of Medicine, King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.
  • Aldekhyl S; Intensive Care Department, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia.
  • Al-Dorzi HM; College of Medicine, King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.
  • Abdukahil SA; Intensive Care Department, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia.
  • Al Harbi MK; College of Medicine, King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.
  • Al Haji H; Intensive Care Department, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia.
  • Al Mutairi M; College of Medicine, King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.
  • Al Zumai O; Intensive Care Department, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia.
  • Al Qasim E; College of Medicine, King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.
  • Al Wehaibi W; College of Medicine, King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.
  • Al Qahtani S; Department of Anesthesia, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia.
  • Al-Hameed F; Respiratory Services Department, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia.
  • Chalabi J; Respiratory Services Department, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia.
  • Alshahrani M; Respiratory Services Department, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia.
  • Albrahim T; College of Applied Medical Sciences, King Saud bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia.
  • Alharthy A; Intensive Care Department, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia.
  • Mady A; College of Medicine, King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.
  • Bin Eshaq A; Intensive Care Department, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia.
  • Al Bshabshe AA; College of Medicine, King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.
  • Al Aseri Z; Intensive Care Department, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia.
  • Al Duhailib Z; College of Medicine, King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.
  • Kharaba A; Intensive Care Department, Ministry of National Guard Health Affairs, Jeddah, Saudi Arabia.
  • Alqahtani R; King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Jeddah, Saudi Arabia.
  • Al Ghamdi A; Intensive Care Department, Ministry of National Guard Health Affairs, Al Ahsa, Saudi Arabia.
  • Altalag A; King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Al Ahsa, Saudi Arabia.
  • Alghamdi K; Departments of Emergency and Critical Care, Imam Abdulrahman Bin Faisal University, King Fahd Hospital of the University, Al Khobar, Saudi Arabia.
  • Almaani M; Department of Critical Care, Imam Abdulrahman Bin Faisal University, King Fahad Hospital of the University, Al Khobar, Saudi Arabia.
  • Algethamy H; Intensive Care Department, King Saud Medical City, Riyadh, Saudi Arabia.
  • Al Aqeily A; Intensive Care Department, King Saud Medical City, Riyadh, Saudi Arabia.
  • Al Baseet F; College of Medicine, Tanta University, Tanta, Egypt.
  • Al Samannoudi H; Intensive Care Department, King Khalid Hospital Najran, Najran, Saudi Arabia.
  • Al Obaidi M; College of Medicine, King Khalid University, Abha, Saudi Arabia.
  • Ismaiel YT; Intensive Care Department, Aseer Central Hospital, Abha, Saudi Arabia.
  • Al-Fares AA; Departments of Emergency Medicine and Critical Care, College of Medicine, King Saud University, Riyadh, Saudi Arabia.
BMJ Open ; 11(8): e052169, 2021 08 26.
Article in English | MEDLINE | ID: covidwho-1376510
ABSTRACT

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 11 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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Respiratory Insufficiency / Noninvasive Ventilation / COVID-19 Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Humans Language: English Journal: BMJ Open Year: 2021 Document Type: Article Affiliation country: Bmjopen-2021-052169

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Respiratory Insufficiency / Noninvasive Ventilation / COVID-19 Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Humans Language: English Journal: BMJ Open Year: 2021 Document Type: Article Affiliation country: Bmjopen-2021-052169