A feasibility randomised controlled trial of targeted oxygen therapy in mechanically ventilated critically ill patients
A feasibility randomised controlled trial of targeted oxygen therapy in mechanically ventilated critically ill patients
Background: Despite oxygen being the commonest drug administered to critically ill patients we do not know which oxygen saturation (SpO2) target results in optimal survival outcomes in those receiving mechanical ventilation. We therefore conducted a feasibility randomised controlled trial in the United Kingdom (UK) to assess whether it would be possible to host a larger national multi-centre trial to evaluate oxygenation targets in mechanically ventilated patients.
Methods: We set out to recruit 60 participants across two sites into a trial in which they were randomised to receive conservative oxygenation (SpO2 88–92%) or usual care (control – SpO2 ≥96%). The primary outcome was feasibility; factors related to safety and clinical outcomes were also assessed.
Results: A total of 34 patients were recruited into the study until it was stopped due to time constraints. A number of key barriers to success were identified during the course of the study. The conservative oxygenation intervention was feasible and appeared to be safe in this small patient cohort and it achieved wide separation of the median time-weighted average (IQR) SpO2 at 91% (90–92%) in conservative oxygenation group versus 97% (96–97%) in control group.
Conclusion: Whilst conservative oxygenation was a feasible and safe intervention which achieved clear group separation in oxygenation levels, the model used in this trial will require alterations to improve future participant recruitment rates in the UK.
critical illness, hypoxaemia, intensive care, mechanical ventilation, Oxygen
280-287
Martin, Daniel S.
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McNeil, Margaret
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Brew-Graves, Chris
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Filipe, Helder
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O’Driscoll, Ronan
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Stevens, Jia Liu
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Burnish, Rachel
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Cumpstey, Andrew F.
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Williams, Norman R.
eb882137-3f53-427a-b387-24fc921f57aa
Mythen, Michael G.
940f5be7-e5bc-4a90-94aa-09fdc658caad
Grocott, Michael P.W.
1e87b741-513e-4a22-be13-0f7bb344e8c2
November 2021
Martin, Daniel S.
3e441b48-9221-4308-8ae6-49cbde20753f
McNeil, Margaret
3b47583f-4d0b-4856-acea-270408b83c67
Brew-Graves, Chris
4756d2b6-dca1-49b3-b70a-ac9a8951b263
Filipe, Helder
f727c9f4-9d9f-4ac1-93d3-e9d819bf8855
O’Driscoll, Ronan
b75acc03-e639-40d4-a155-432919a6e824
Stevens, Jia Liu
b7a09e0e-7fa1-4486-82f3-5ac64820f0ff
Burnish, Rachel
a719a04e-b8ee-472b-ac06-91f4a2b28589
Cumpstey, Andrew F.
cd040417-5e62-41d2-8640-1ec8905858a7
Williams, Norman R.
eb882137-3f53-427a-b387-24fc921f57aa
Mythen, Michael G.
940f5be7-e5bc-4a90-94aa-09fdc658caad
Grocott, Michael P.W.
1e87b741-513e-4a22-be13-0f7bb344e8c2
Martin, Daniel S., McNeil, Margaret, Brew-Graves, Chris, Filipe, Helder, O’Driscoll, Ronan, Stevens, Jia Liu, Burnish, Rachel, Cumpstey, Andrew F., Williams, Norman R., Mythen, Michael G. and Grocott, Michael P.W.
(2021)
A feasibility randomised controlled trial of targeted oxygen therapy in mechanically ventilated critically ill patients.
Journal of the Intensive Care Society, 22 (4), .
(doi:10.1177/17511437211010031).
Abstract
Background: Despite oxygen being the commonest drug administered to critically ill patients we do not know which oxygen saturation (SpO2) target results in optimal survival outcomes in those receiving mechanical ventilation. We therefore conducted a feasibility randomised controlled trial in the United Kingdom (UK) to assess whether it would be possible to host a larger national multi-centre trial to evaluate oxygenation targets in mechanically ventilated patients.
Methods: We set out to recruit 60 participants across two sites into a trial in which they were randomised to receive conservative oxygenation (SpO2 88–92%) or usual care (control – SpO2 ≥96%). The primary outcome was feasibility; factors related to safety and clinical outcomes were also assessed.
Results: A total of 34 patients were recruited into the study until it was stopped due to time constraints. A number of key barriers to success were identified during the course of the study. The conservative oxygenation intervention was feasible and appeared to be safe in this small patient cohort and it achieved wide separation of the median time-weighted average (IQR) SpO2 at 91% (90–92%) in conservative oxygenation group versus 97% (96–97%) in control group.
Conclusion: Whilst conservative oxygenation was a feasible and safe intervention which achieved clear group separation in oxygenation levels, the model used in this trial will require alterations to improve future participant recruitment rates in the UK.
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More information
Accepted/In Press date: 2021
e-pub ahead of print date: 8 April 2021
Published date: November 2021
Additional Information:
Funding Information:
This publication presents independent research funded by the National Institute for Health Research (NIHR). The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care.
Funding Information:
The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: DSM and MGM are in part funded by the UCLH/UCL NIHR Biomedical Research Centre. MPWG is in part funded by the Southampton NIHR Biomedical Research Centre.
Funding Information:
This project was funded by a National Institute for Health Research (NIHR) award (PB-PG-0815-20006).
Publisher Copyright:
© The Intensive Care Society 2021.
Keywords:
critical illness, hypoxaemia, intensive care, mechanical ventilation, Oxygen
Identifiers
Local EPrints ID: 451046
URI: http://eprints.soton.ac.uk/id/eprint/451046
ISSN: 1751-1437
PURE UUID: 944ed4c6-883c-43ef-a979-a11835e0aee5
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Date deposited: 03 Sep 2021 16:42
Last modified: 13 Dec 2024 03:05
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Contributors
Author:
Daniel S. Martin
Author:
Margaret McNeil
Author:
Chris Brew-Graves
Author:
Helder Filipe
Author:
Ronan O’Driscoll
Author:
Jia Liu Stevens
Author:
Rachel Burnish
Author:
Andrew F. Cumpstey
Author:
Norman R. Williams
Author:
Michael G. Mythen
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