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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Ms Tasnin Shahid
+44 (0)20 7269 9277
tasnin.shahid@icnarc.org


Prof Daniel Martin
+44 (0)2072699277
daniel.martin@plymouth.ac.uk


More information about this study, what is involved and how to take part can be found on the study website.

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Be Part of Research - Trial Details - Intensive care unit randomised trial comparing two approaches to oxygen therapy (UK-ROX)
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Intensive care unit randomised trial comparing two approaches to oxygen therapy (UK-ROX)

Not Recruiting

Open to: All Genders

Age: Adult

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Medical Conditions

Invasive ventilation in intensive care

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Each year, around 184,000 patients are admitted to NHS intensive care units (ICUs) and over 30% require help with their breathing using a ventilator (breathing machine). Giving oxygen through the ventilator is an essential part of this treatment. However, currently it is not known how much oxygen should be given to patients to optimise their recovery. Both too much and too little oxygen may cause harm. The concentration of oxygen given through the ventilator is adjusted according to how much oxygen can be detected in a patient’s blood, known as 'oxygen saturation'. Some studies have shown that in unwell hospitalised patients, having a lower, rather than higher, oxygen saturation may more be beneficial. The aim of this study is to find out whether using a lower oxygen target (conservative oxygen therapy) to guide oxygen treatment might lead to better outcomes for patients when compared with the approach currently used in NHS ICUs (usual oxygen therapy).

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

03 May 2021 27 Nov 2024

Publications

2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38737312/ (added 08/07/2024)

Eligible patients will be randomly allocated to either the conservative oxygen therapy or the usual oxygen therapy group. If a patient is allocated to conservative oxygen therapy (intervention) group, the lowest concentration of oxygen possible should be administered to maintain the patient’s oxygen at 90 (±2)%. For patients receiving oxygen, it should not rise above 92%. Alarms should be set to prevent an SpO₂ lower than 88% and higher than 92%. If a patient is allocated to the usual oxygen therapy (control) group, the clinical team will continue to deliver oxygen therapy as per local practice and clinical management will not be influenced by the trial. The researchers will follow all patients up to 90 days later by ‘linking’ study data with routinely collected national records. They will also send a questionnaire to around 15% of surviving patients at 90 days to find out about their quality of life and use of health services. They will find out if conservative oxygen therapy was more effective than usual oxygen therapy by comparing the number of patients alive in each group at 90 days.


Patients aged 18 and over receiving invasive mechanical ventilation and supplemental oxygen from about 100 UK NHS ICUs

You can take part if:



You may not be able to take part if:


1. Previously randomised into UK-ROX in the last 90 days2. The clinician considers that one study treatment arm is either indicated or contraindicated.

Removed 20/04/2021:A data dictionary will contain relevant examples of conditions where clinicians may exclude patients (at their discretion) because conservative oxygen therapy is either indicated or contraindicated (e.g. chronic lung diseases, receiving hyperbaric oxygen, prior bleomycin exposure, carbon monoxide poisoning).

Added 22/02/2021:3. Currently receiving extracorporeal membrane oxygenation (ECMO)


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

Extremely high and extremely low oxygen levels can cause damage to the body. The purpose of this study is to look at the effect of a small reduction in oxygen given. The benefits and risks of giving slightly less oxygen are unclear at this time, which is why this research is needed.

Ms Tasnin Shahid
+44 (0)20 7269 9277
tasnin.shahid@icnarc.org


Prof Daniel Martin
+44 (0)2072699277
daniel.martin@plymouth.ac.uk



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by Intensive Care National Audit & Research Centre (ICNARC) and funded by NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); Grant Codes: NIHR130508.



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Read full details for Trial ID: ISRCTN13384956

Or CPMS 46926

Last updated 21 March 2025

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