The University of Southampton
University of Southampton Institutional Repository

Protocol for a feasibility randomised controlled trial of targeted oxygen therapy in mechanically ventilated critically ill patients

Protocol for a feasibility randomised controlled trial of targeted oxygen therapy in mechanically ventilated critically ill patients
Protocol for a feasibility randomised controlled trial of targeted oxygen therapy in mechanically ventilated critically ill patients

Introduction Oxygen is the most commonly administered drug to mechanically ventilated critically ill adults, yet little is known about the optimum oxygen saturation (SpO 2) target for these patients; the current standard of care is an SpO 2 of 96% or above. Small pilot studies have demonstrated that permissive hypoxaemia (aiming for a lower SpO 2 than normal by using a lower fractional inspired oxygen concentration (FIO 2)) can be achieved in the critically ill and appears to be safe. This approach has not been evaluated in a National Health Service setting. It is possible that permissive hypoxaemia may be beneficial to critically ill patients thus it requires robust evaluation. Methods and analysis Targeted OXygen therapY in Critical illness (TOXYC) is a feasibility randomised controlled trial (RCT) to evaluate whether recruiting patients to a study of permissive hypoxaemia is possible in the UK. It will also investigate biological mechanisms that may underlie the links between oxygenation and patient outcomes. Mechanically ventilated patients with respiratory failure will be recruited from critical care units at two sites and randomised (1:1 ratio) to an SpO 2 target of either 88%-92% or ≥96% while intubated with an endotracheal tube. Clinical teams can adjust FIO 2 and ventilator settings as they wish to achieve these targets. Clinical information will be collected before, during and after the intervention and blood samples taken to measure markers of systemic oxidative stress. The primary outcome of this study is feasibility, which will be assessed by recruitment rate, protocol adherence and withdrawal rates. Secondary outcomes will include a comparison of standard critical care outcome measures between the two intervention groups, and the measurement of biomarkers of systemic oxidative stress. The results will be used to calculate a sample size, likely number of sites and overall length of time required for a subsequent large multicentre RCT. Ethics and dissemination This study was approved by the London-Harrow Research Ethics Committee on 2 November 2017 (REC Reference 17/LO/1334) and received HRA approval on 13 November 2017. Results from this study will be disseminated in peer-reviewed journals, at medical and scientific meetings, in the NIHR Journals Library and patient information websites. Trial registration number NCT03287466; Pre-results.

artificial respiration, hypoxia, oxidative stress, oxygen, respiratory insufficiency
2044-6055
1-7
Martin, Daniel S.
3e441b48-9221-4308-8ae6-49cbde20753f
Brew-Graves, Chris
4756d2b6-dca1-49b3-b70a-ac9a8951b263
McCartan, Neil
f42e9769-2a87-4e80-b6f4-c774d5a20723
Jell, Gavin
8e01cbee-a745-4a05-8d54-1eaa6d9f9363
Potyka, Ingrid
5e52e7ab-3b3b-4dc1-a2fe-df879ac4217f
Stevens, Jia
b7a09e0e-7fa1-4486-82f3-5ac64820f0ff
Williams, Norman R.
eb882137-3f53-427a-b387-24fc921f57aa
McNeil, Margaret
3b47583f-4d0b-4856-acea-270408b83c67
O'Driscoll, B. Ronan
3e54d671-6070-45fa-b5cc-8cb128c24fcb
Mythen, Monty
ced4210c-1c97-4e00-aa51-58dea2959848
Grocott, Michael P.W.
1e87b741-513e-4a22-be13-0f7bb344e8c2
Martin, Daniel S.
3e441b48-9221-4308-8ae6-49cbde20753f
Brew-Graves, Chris
4756d2b6-dca1-49b3-b70a-ac9a8951b263
McCartan, Neil
f42e9769-2a87-4e80-b6f4-c774d5a20723
Jell, Gavin
8e01cbee-a745-4a05-8d54-1eaa6d9f9363
Potyka, Ingrid
5e52e7ab-3b3b-4dc1-a2fe-df879ac4217f
Stevens, Jia
b7a09e0e-7fa1-4486-82f3-5ac64820f0ff
Williams, Norman R.
eb882137-3f53-427a-b387-24fc921f57aa
McNeil, Margaret
3b47583f-4d0b-4856-acea-270408b83c67
O'Driscoll, B. Ronan
3e54d671-6070-45fa-b5cc-8cb128c24fcb
Mythen, Monty
ced4210c-1c97-4e00-aa51-58dea2959848
Grocott, Michael P.W.
1e87b741-513e-4a22-be13-0f7bb344e8c2

Martin, Daniel S., Brew-Graves, Chris, McCartan, Neil, Jell, Gavin, Potyka, Ingrid, Stevens, Jia, Williams, Norman R., McNeil, Margaret, O'Driscoll, B. Ronan, Mythen, Monty and Grocott, Michael P.W. (2019) Protocol for a feasibility randomised controlled trial of targeted oxygen therapy in mechanically ventilated critically ill patients. BMJ Open, 9 (1), 1-7, [e021674]. (doi:10.1136/bmjopen-2018-021674).

Record type: Article

Abstract

Introduction Oxygen is the most commonly administered drug to mechanically ventilated critically ill adults, yet little is known about the optimum oxygen saturation (SpO 2) target for these patients; the current standard of care is an SpO 2 of 96% or above. Small pilot studies have demonstrated that permissive hypoxaemia (aiming for a lower SpO 2 than normal by using a lower fractional inspired oxygen concentration (FIO 2)) can be achieved in the critically ill and appears to be safe. This approach has not been evaluated in a National Health Service setting. It is possible that permissive hypoxaemia may be beneficial to critically ill patients thus it requires robust evaluation. Methods and analysis Targeted OXygen therapY in Critical illness (TOXYC) is a feasibility randomised controlled trial (RCT) to evaluate whether recruiting patients to a study of permissive hypoxaemia is possible in the UK. It will also investigate biological mechanisms that may underlie the links between oxygenation and patient outcomes. Mechanically ventilated patients with respiratory failure will be recruited from critical care units at two sites and randomised (1:1 ratio) to an SpO 2 target of either 88%-92% or ≥96% while intubated with an endotracheal tube. Clinical teams can adjust FIO 2 and ventilator settings as they wish to achieve these targets. Clinical information will be collected before, during and after the intervention and blood samples taken to measure markers of systemic oxidative stress. The primary outcome of this study is feasibility, which will be assessed by recruitment rate, protocol adherence and withdrawal rates. Secondary outcomes will include a comparison of standard critical care outcome measures between the two intervention groups, and the measurement of biomarkers of systemic oxidative stress. The results will be used to calculate a sample size, likely number of sites and overall length of time required for a subsequent large multicentre RCT. Ethics and dissemination This study was approved by the London-Harrow Research Ethics Committee on 2 November 2017 (REC Reference 17/LO/1334) and received HRA approval on 13 November 2017. Results from this study will be disseminated in peer-reviewed journals, at medical and scientific meetings, in the NIHR Journals Library and patient information websites. Trial registration number NCT03287466; Pre-results.

Text
ae021674.full - Version of Record
Available under License Creative Commons Attribution.
Download (528kB)

More information

Accepted/In Press date: 29 October 2018
Published date: 1 January 2019
Keywords: artificial respiration, hypoxia, oxidative stress, oxygen, respiratory insufficiency

Identifiers

Local EPrints ID: 427960
URI: http://eprints.soton.ac.uk/id/eprint/427960
ISSN: 2044-6055
PURE UUID: 8c9e5d34-361c-4fdd-987e-ceb79d38d558
ORCID for Michael P.W. Grocott: ORCID iD orcid.org/0000-0002-9484-7581

Catalogue record

Date deposited: 06 Feb 2019 17:30
Last modified: 07 Oct 2020 01:56

Export record

Altmetrics

Contributors

Author: Daniel S. Martin
Author: Chris Brew-Graves
Author: Neil McCartan
Author: Gavin Jell
Author: Ingrid Potyka
Author: Jia Stevens
Author: Norman R. Williams
Author: Margaret McNeil
Author: B. Ronan O'Driscoll
Author: Monty Mythen

University divisions

Download statistics

Downloads from ePrints over the past year. Other digital versions may also be available to download e.g. from the publisher's website.

View more statistics

Atom RSS 1.0 RSS 2.0

Contact ePrints Soton: eprints@soton.ac.uk

ePrints Soton supports OAI 2.0 with a base URL of http://eprints.soton.ac.uk/cgi/oai2

This repository has been built using EPrints software, developed at the University of Southampton, but available to everyone to use.

We use cookies to ensure that we give you the best experience on our website. If you continue without changing your settings, we will assume that you are happy to receive cookies on the University of Southampton website.

×