Information for patients

What is the purpose of the study?

Oxygen is one of the most common treatments given to patients in the intensive care unit. Doctors and nurses adjust the amount of extra oxygen given to patients based on how much oxygen there is in their blood.

Currently, there is not much evidence about the best amount of extra oxygen to give to patients during treatment. This means that different blood oxygen targets are used in different hospitals, but usually these targets will be around 96-97% of oxygen in the blood. Recent research suggests that giving slightly less extra oxygen may be beneficial, but more research is needed.

We are therefore studying the effect of a small reduction in how much extra oxygen we give. The full benefits and risks of giving slightly less extra oxygen are unclear at this time, which is why this research is needed. Our aim is to find out whether using slightly lower amounts of extra oxygen lead to better outcomes.

This is a large national study. We hope to include 16,500 patients from around 100 NHS intensive care units across the country. We hope that this research will help to improve the future treatment of patients in intensive care in the UK and around the world.  

What does the study involve?

When people are put on a breathing machine (ventilator) and given extra oxygen, it is usually an emergency situation where decisions need to be made very quickly. The clinical team therefore enrol patients into the research and focus on delivering the treatment.

Half of the patients will be treated using the slightly lower oxygen target of around 90%. The other half will receive the usual amount of extra oxygen that they would have received if they were not involved in the study.

Patients and/or their relatives are then informed about the research and approached for their consent/agreement once the emergency situation is over. This method of consent is commonly used in studies in the intensive care unit.

All patients involved in the trial are monitored closely and will receive all standard NHS care as and when they need it. 

What information is collected?

Some information about participants’ hospital stay is collected from hospital medical records. Other important health information is collected from national NHS databases. Some participants are also be sent a short health questionnaire three months after becoming involved in the study. At the end of the study, all of this information will allow us to compare the two groups in the study to find out which treatment is most beneficial. All information collected is kept secure and confidential. You can read our Privacy Policy here.

Who has reviewed the study?

All NHS research is reviewed by an independent group of people, called a Research Ethics Committee, to protect your interests. This study has been reviewed and approved by the South Central – Oxford C Research Ethics Committee.

Who is funding and organising the study?

The study is funded by the National Institute for Health Research (NIHR) Health Technology Assessment Programme. Professor Daniel Martin is the senior intensive care consultant who is leading the study along with Mr Paul Mouncey who is an experienced researcher. The Intensive Care National Audit & Research Centre (ICNARC) are managing the study.

Do I have to take part?

It is up to participants if they want to take part or not. This decision does not affect any of the future care participants receive. You can change your mind at any time. If you have any questions or no longer wish to take part, please contact:

Tasnin Shahid, Trial Manager

uk-rox@icnarc.org

020 7269 9277

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