High versus low positive end-expiratory pressure setting in patients receiving veno-venous extracorporeal membrane oxygenation support for severe acute respiratory distress syndrome : study protocol for the multicentre, randomised ExPress SAVER Trial
© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ..
INTRODUCTION: While limiting the tidal volume to 6 mL/kg during veno-venous extracorporeal membrane oxygenation (V-V ECMO) to ameliorate lung injury in patients with acute respiratory distress syndrome (ARDS) is widely accepted, the best setting for positive end-expiratory pressure (PEEP) is still controversial. This study is being conducted to investigate whether a higher PEEP setting (15 cmH2O) during V-V ECMO can decrease the duration of ECMO support needed in patients with severe ARDS, as compared with a lower PEEP setting.
METHODS AND ANALYSIS: The study is an investigator-initiated, multicentre, open-label, two-arm, randomised controlled trial conducted with the participation of 20 intensive care units (ICUs) at academic as well as non-academic hospitals in Japan. The subjects of the study are patients with severe ARDS who require V-V ECMO support. Eligible patients will be randomised equally to the high PEEP group or low PEEP group. Recruitment to the study will continue until a total of 210 patients with ARDS requiring V-V ECMO support have been randomised. In the high PEEP group, PEEP will be set at 15 cmH2O from the start of V-V ECMO until the trials for liberation from V-V ECMO (or until day 28 after the allocation), while in the low PEEP group, the PEEP will be set at 5 cmH2O. Other treatments will be the same in the two groups. The primary endpoint of the study is the number of ECMO-free days until day 28, defined as the length of time (in days) from successful libration from V-V ECMO to day 28. The secondary endpoints are mortality on day 28, in-hospital mortality on day 60, ventilator-free days during the first 60 days and length of ICU stay.
ETHICS AND DISSEMINATION: Ethics approval for the trial at all the participating hospitals was obtained on 27 September 2022, by central ethics approval (IRB at Hiroshima University Hospital, C2022-0006). The results of this study will be presented at domestic and international medical congresses, and also published in scientific journals.
TRIAL REGISTRATION NUMBER: The Japan Registry of Clinical Trials jRCT1062220062. Registered on 28 September 2022.
PROTOCOL VERSION: 28 March 2023, version 4.0.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:13 |
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| Enthalten in: |
BMJ open - 13(2023), 10 vom: 18. Okt., Seite e072680 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Nishikimi, Mitsuaki [VerfasserIn] |
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| Links: |
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| Themen: |
Adult thoracic medicine |
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| Anmerkungen: |
Date Completed 23.10.2023 Date Revised 29.10.2023 published: Electronic Citation Status MEDLINE |
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| doi: |
10.1136/bmjopen-2023-072680 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| 245 | 1 | 0 | |a High versus low positive end-expiratory pressure setting in patients receiving veno-venous extracorporeal membrane oxygenation support for severe acute respiratory distress syndrome |b study protocol for the multicentre, randomised ExPress SAVER Trial |
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| 500 | |a Date Revised 29.10.2023 | ||
| 500 | |a published: Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. | ||
| 520 | |a INTRODUCTION: While limiting the tidal volume to 6 mL/kg during veno-venous extracorporeal membrane oxygenation (V-V ECMO) to ameliorate lung injury in patients with acute respiratory distress syndrome (ARDS) is widely accepted, the best setting for positive end-expiratory pressure (PEEP) is still controversial. This study is being conducted to investigate whether a higher PEEP setting (15 cmH2O) during V-V ECMO can decrease the duration of ECMO support needed in patients with severe ARDS, as compared with a lower PEEP setting | ||
| 520 | |a METHODS AND ANALYSIS: The study is an investigator-initiated, multicentre, open-label, two-arm, randomised controlled trial conducted with the participation of 20 intensive care units (ICUs) at academic as well as non-academic hospitals in Japan. The subjects of the study are patients with severe ARDS who require V-V ECMO support. Eligible patients will be randomised equally to the high PEEP group or low PEEP group. Recruitment to the study will continue until a total of 210 patients with ARDS requiring V-V ECMO support have been randomised. In the high PEEP group, PEEP will be set at 15 cmH2O from the start of V-V ECMO until the trials for liberation from V-V ECMO (or until day 28 after the allocation), while in the low PEEP group, the PEEP will be set at 5 cmH2O. Other treatments will be the same in the two groups. The primary endpoint of the study is the number of ECMO-free days until day 28, defined as the length of time (in days) from successful libration from V-V ECMO to day 28. The secondary endpoints are mortality on day 28, in-hospital mortality on day 60, ventilator-free days during the first 60 days and length of ICU stay | ||
| 520 | |a ETHICS AND DISSEMINATION: Ethics approval for the trial at all the participating hospitals was obtained on 27 September 2022, by central ethics approval (IRB at Hiroshima University Hospital, C2022-0006). The results of this study will be presented at domestic and international medical congresses, and also published in scientific journals | ||
| 520 | |a TRIAL REGISTRATION NUMBER: The Japan Registry of Clinical Trials jRCT1062220062. Registered on 28 September 2022 | ||
| 520 | |a PROTOCOL VERSION: 28 March 2023, version 4.0 | ||
| 650 | 4 | |a Clinical Trial Protocol | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a adult thoracic medicine | |
| 650 | 4 | |a clinical trial | |
| 650 | 4 | |a respiratory infections | |
| 700 | 1 | |a Ohshimo, Shinichiro |e verfasserin |4 aut | |
| 700 | 1 | |a Hamaguchi, Jun |e verfasserin |4 aut | |
| 700 | 1 | |a Fujizuka, Kenji |e verfasserin |4 aut | |
| 700 | 1 | |a Hagiwara, Yoshihiro |e verfasserin |4 aut | |
| 700 | 1 | |a Anzai, Tatsuhiko |e verfasserin |4 aut | |
| 700 | 1 | |a Ishii, Junki |e verfasserin |4 aut | |
| 700 | 1 | |a Ogata, Yoshitaka |e verfasserin |4 aut | |
| 700 | 1 | |a Aokage, Toshiyuki |e verfasserin |4 aut | |
| 700 | 1 | |a Ikeda, Tokuji |e verfasserin |4 aut | |
| 700 | 1 | |a Yagi, Tsukasa |e verfasserin |4 aut | |
| 700 | 1 | |a Suzuki, Ginga |e verfasserin |4 aut | |
| 700 | 1 | |a Ishikura, Ken |e verfasserin |4 aut | |
| 700 | 1 | |a Katsuta, Ken |e verfasserin |4 aut | |
| 700 | 1 | |a Konno, Daisuke |e verfasserin |4 aut | |
| 700 | 1 | |a Hattori, Noriyuki |e verfasserin |4 aut | |
| 700 | 1 | |a Nakamura, Tomoyuki |e verfasserin |4 aut | |
| 700 | 1 | |a Matsumura, Yosuke |e verfasserin |4 aut | |
| 700 | 1 | |a Kasugai, Daisuke |e verfasserin |4 aut | |
| 700 | 1 | |a Kikuchi, Hitoshi |e verfasserin |4 aut | |
| 700 | 1 | |a Iino, Tatsuhiko |e verfasserin |4 aut | |
| 700 | 1 | |a Kai, Shinichi |e verfasserin |4 aut | |
| 700 | 1 | |a Hashimoto, Haruka |e verfasserin |4 aut | |
| 700 | 1 | |a Yoshida, Takeshi |e verfasserin |4 aut | |
| 700 | 1 | |a Igarashi, Yumi |e verfasserin |4 aut | |
| 700 | 1 | |a Ogura, Takayuki |e verfasserin |4 aut | |
| 700 | 1 | |a Matsumura, Kazuki |e verfasserin |4 aut | |
| 700 | 1 | |a Shimizu, Keiki |e verfasserin |4 aut | |
| 700 | 1 | |a Nakamura, Mitsunobu |e verfasserin |4 aut | |
| 700 | 1 | |a Ichiba, Shingo |e verfasserin |4 aut | |
| 700 | 1 | |a Takahashi, Kunihiko |e verfasserin |4 aut | |
| 700 | 1 | |a Shime, Nobuaki |e verfasserin |4 aut | |
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