Helmet Non-Invasive Ventilation for COVID-19 Patients (Helmet-COVID): study protocol for a multicentre randomised controlled trial

被引：4

作者：

Arabi, Yaseen M. ^{[1
,2
]}

Tlayjeh, Haytham ^{[1
,2
]}

Aldekhyl, Sara ^{[1
,2
]}

Al-Dorzi, Hasan M. ^{[1
,2
]}

Abdukahil, Sheryl Ann ^{[1
,2
]}

Al Harbi, Mohammad Khulaif ^{[2
,3
]}

Al Haji, Husain ^{[4
]}

Al Mutairi, Mohammed ^{[4
]}

Al Zumai, Omar ^{[4
,5
]}

Al Qasim, Eman ^{[1
,2
]}

Al Wehaibi, Wedyan ^{[1
,2
]}

Al Qahtani, Saad ^{[1
,2
]}

Al-Hameed, Fahad ^{[6
,7
]}

Chalabi, Jamal ^{[8
,9
]}

Alshahrani, Mohammed ^{[10
,11
]}

Albrahim, Talal ^{[12
]}

Alharthy, Abdulrahman ^{[13
]}

Mady, Ahmed ^{[13
,14
]}

Bin Eshaq, Abdulhadi ^{[15
]}

Al Bshabshe, Ali A. ^{[16
,17
]}

Al Aseri, Zohair ^{[18
,19
,20
]}

Al Duhailib, Zainab ^{[21
]}

Kharaba, Ayman ^{[22
,23
]}

Alqahtani, Rakan ^{[24
]}

Al Ghamdi, Adnan ^{[25
]}

Altalag, Ali ^{[25
]}

Alghamdi, Khalid ^{[26
]}

Almaani, Mohammed ^{[27
]}

Algethamy, Haifa ^{[28
]}

Al Aqeily, Ahmad ^{[4
]}

Al Baseet, Faisal ^{[4
]}

Al Samannoudi, Hashem ^{[4
]}

Al Obaidi, Mohammed ^{[4
]}

Ismaiel, Yassin T. ^{[4
]}

Al-Fares, Abdulrahman A. ^{[29
]}

机构：

[1] Minist Natl Guard Hlth Affairs, Intens Care Dept, Riyadh, Saudi Arabia

[2] King Saud Bin Abdulaziz Univ Hlth Sci, Coll Med, King Abdullah Int Med Res Ctr, Riyadh, Saudi Arabia

[3] Minist Natl Guard Hlth Affairs, Dept Anesthesia, Riyadh, Saudi Arabia

[4] Minist Natl Guard Hlth Affairs, Resp Serv Dept, Riyadh, Saudi Arabia

[5] King Saud Bin Abdulaziz Univ Hlth Sci, Coll Appl Med Sci, Riyadh, Saudi Arabia

[6] Minist Natl Guard Hlth Affairs, Intens Care Dept, Jeddah, Saudi Arabia

[7] King Saud Bin Abdulaziz Univ Hlth Sci, King Abdullah Int Med Res Ctr, Jeddah, Saudi Arabia

[8] Minist Natl Guard Hlth Affairs, Intens Care Dept, Al Hasa, Saudi Arabia

[9] King Saud Bin Abdulaziz Univ Hlth Sci, King Abdullah Int Med Res Ctr, Al Hasa, Saudi Arabia

[10] Imam Abdulrahman Bin Faisal Univ, King Fahd Hosp Univ, Dept Emergency, Al Khobar, Saudi Arabia

[11] Imam Abdulrahman Bin Faisal Univ, King Fahd Hosp Univ, Dept Crit Care, Al Khobar, Saudi Arabia

[12] Imam Abdulrahman Bin Faisal Univ, King Fahad Hosp Univ, Dept Crit Care, Al Khobar, Saudi Arabia

[13] King Saud Med City, Intens Care Dept, Riyadh, Saudi Arabia

[14] Tanta Univ, Coll Med, Tanta, Egypt

[15] King Khalid Hosp Najran, Intens Care Dept, Najran, Saudi Arabia

[16] King Khalid Univ, Coll Med, Abha, Saudi Arabia

[17] Aseer Cent Hosp, Intens Care Dept, Abha, Saudi Arabia

[18] King Saud Univ, Coll Med, Dept Emergency Med, Riyadh, Saudi Arabia

[19] King Saud Univ, Coll Med, Dept Crit Care, Riyadh, Saudi Arabia

[20] King Saud Univ, Coll Med, Riyadh, Saudi Arabia

[21] King Faisal Specialist Hosp & Res Ctr, Adult Crit Care Dept, Riyadh, Saudi Arabia

[22] King Fahad Hosp Madinah, Pulm Dept, Madinah, Saudi Arabia

[23] King Fahad Hosp Madinah, Crit Care Dept, Madinah, Saudi Arabia

[24] King Saud Univ, Coll Med, Dept Crit Care Med, Riyadh, Saudi Arabia

[25] Prince Sultan Mil Med City, Dept Intens Care Serv, Riyadh, Saudi Arabia

[26] King Faisal Specialist Hosp & Res Ctr, Intens Care Dept, Jeddah, Saudi Arabia

[27] King Fahad Med City, Dept Pulm & Crit Care Med, Riyadh, Saudi Arabia

[28] King Abdulaziz Univ Hosp, Dept Anesthesia & Crit Care, Jeddah, Saudi Arabia

[29] Al Amiri Hosp, Dept Anesthesia Crit Care Med & Pain Med, Kuwait, Kuwait

来源：

BMJ OPEN | 2021年 / 11卷 / 08期

关键词：

adult intensive & critical care; respiratory medicine (see thoracic medicine); COVID-19; POSITIVE AIRWAY PRESSURE; OXYGEN-THERAPY; CARE;

D O I：

10.1136/bmjopen-2021-052169

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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.

引用

页数：7

共 29 条

[1] Alhazzani W, 2020, INTENS CARE MED, V46, P854, DOI [10.1097/CCM.0000000000004363, 10.1007/s00134-020-06022-5]
[2] Surviving Sepsis Campaign Guidelines on the Management of Adults With Coronavirus Disease 2019 (COVID-19) in the ICU: First Update
Alhazzani, Waleed
Evans, Laura
Alshamsi, Fayez
Moller, Morten Hylander
Ostermann, Marlies
Prescott, Hallie C.
Arabi, Yaseen M.
Loeb, Mark
Gong, Michelle Ng
Fan, Eddy
Oczkowski, Simon
Levy, Mitchell M.
Derde, Lennie
Dzierba, Amy
Du, Bin
Machado, Flavia
Wunsch, Hannah
Crowther, Mark
Cecconi, Maurizio
Koh, Younsuck
Burry, Lisa
Chertow, Daniel S.
Szczeklik, Wojciech
Belley-Cote, Emilie
Greco, Massimiliano
Bala, Malgorzata
Zarychanski, Ryan
Kesecioglu, Jozef
McGeer, Allison
Mermel, Leonard
Mammen, Manoj J.
Myatra, Sheila Nainan
Arrington, Amy
Kleinpell, Ruth
Citerio, Giuseppe
Lewis, Kimberley
Bridges, Elizabeth
Memish, Ziad A.
Hammond, Naomi
Hayden, Frederick G.
Alshahrani, Muhammed
Al Duhailib, Zainab
Martin, Greg S.
Kaplan, Lewis J.
Coopersmith, Craig M.
Antonelli, Massimo
Rhodes, Andrew
[J]. CRITICAL CARE MEDICINE, 2021, 49 (03) : E219 - E234
[3] [Anonymous], 2020, LANCET RESP MED, DOI DOI 10.1016/S2213-2600(20)30110-7
[4] [Anonymous], CORONAVIRUS DIS COVI
[5] [Anonymous], 2020, SAUDI CRIT CARE J, DOI 10.4103/sccj.sccj_15_20
[6] National Approach to Standardize and Improve Mechanical Ventilation
Arabi, Yaseen M.
Al Aseri, Zohair
Alaama, Tareef
Alqahtani, Abdulrahman
Alharthy, Abdulrhman
Almotairi, Abdullah
Al Qasim, Eman
Alzahrani, Abdullah A.
Al Qarni, Mohammed
Abdukahil, Sheryl Ann I.
Al-Hameed, Fahad M.
Mandourah, Yasser
Maghrabi, Khalid
Ghamdi, Adnan
Almekhalfi, Ghaleb
Mady, Ahmed
Qureshi, Ahmed S.
Qushmaq, Ismael
Alshahrani, Mohammed S.
Alkatheri, Mufareh
Saawi, Abdulmohsen
AlHazme, Raed H.
Berenholtz, Sean M.
Latif, Asad
Al-Moamary, Mohamed S.
Mohrij, Saad
[J]. ANNALS OF THORACIC MEDICINE, 2019, 14 (02) : 101 - 105
[7] Use of non-invasive ventilation for patients with COVID-19: a cause for concern?
Arulkumaran, Nishkantha
Brealey, David
Howell, David
Singer, Mervyn
[J]. LANCET RESPIRATORY MEDICINE, 2020, 8 (06) : E45 - E45
[8] Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries
Bellani, Giacomo
Laffey, John G.
Pham, Tai
Fan, Eddy
Brochard, Laurent
Esteban, Andres
Gattinoni, Luciano
van Haren, Frank
Larsson, Anders
McAuley, Daniel F.
Ranieri, Marco
Rubenfeld, Gordon
Thompson, B. Taylor
Wrigge, Hermann
Slutsky, Arthur S.
Pesenti, Antonio
[J]. JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2016, 315 (08): : 788 - 800
[9] Helmet CPAP vs. oxygen therapy in severe hypoxemic respiratory failure due to pneumonia
Brambilla, Anna Maria
Aliberti, Stefano
Prina, Elena
Nicoli, Francesco
Del Forno, Manuela
Nava, Stefano
Ferrari, Giovanni
Corradi, Francesco
Pelosi, Paolo
Bignamini, Angelo
Tarsia, Paolo
Cosentini, Roberto
[J]. INTENSIVE CARE MEDICINE, 2014, 40 (07) : 942 - 949
[10] CDC, 2020, COR DIS 2019 COVID 1

← 1 2 3 →