Active not recruitingPHASE4INTERVENTIONAL

Perioperative UtiLisation of SupplEmental Oxygen

This study, called PERIOPERATIVE UTILISATION OF SUPPLEMENTAL OXYGEN, is trying to find the best amount of oxygen to give patients having surgery under general anaesthetic. The World Health Organisation suggests giving 80% oxygen to prevent infections, but other research suggests that too much oxygen might not always be best. Doctors noticed that patients often receive different amounts of oxygen during surgery already. This research will explore if giving less oxygen (either 55% or 30%) instead of the higher 80% might reduce strain on the body, especially the lungs. They will measure body reactions and recovery for up to 7 days after surgery to understand which oxygen level is safest and most effective.

At a glance

Status

Active not recruiting

Phase

PHASE4

Sponsor

University Hospital Southampton NHS Foundation Trust

Enrolment target

Start

01 Mar 2018

Estimated completion

01 Dec 2026

Anesthesia

What is this study about?

Imagine you're having an operation where you'll be put to sleep with a general anaesthetic. During this time, you'll be given extra oxygen. Doctors usually do this to help you, and the World Health Organisation even suggests a high level of 80% oxygen to try and prevent infections after surgery. However, in other areas of medicine, we're starting to learn that sometimes giving too much oxygen isn't always helpful, and can even be a bit harmful, like for people who've had a heart attack.

Because of this, doctors aren't totally sure how much oxygen is ideal during surgery. In fact, they've noticed that the amount of oxygen given to patients during operations can vary quite a lot from one hospital to another. This study aims to find out if giving a lower amount of oxygen – either 55% or 30% – might actually be better for your body, especially your lungs, compared to the higher 80% level. The researchers believe that a lower amount might put less stress on your body.

To find this out, if you take part, you would be randomly assigned to receive one of these oxygen levels during your surgery. The research team would then carefully look at things like how your body reacts to the oxygen and how well you recover in the first 7 days after your operation. This research is really important because it could help doctors understand the safest and most effective amount of oxygen to give to all patients having surgery in the future.

Key takeaways

This study evaluates oxygen levels during surgery.
It compares 80%, 55%, and 30% oxygen concentrations.
Aims to find the safest and most effective oxygen dose.
Measures body's response and recovery for 7 days.
Could improve future surgical care for patients.
You can withdraw from the study at any time.

Who may be eligible?

This study is looking for adults aged 16 and over to take part. You would need to be having a planned operation that isn't an emergency. Also, as part of your normal anaesthetic, your doctors must already plan to insert a thin tube into an artery (for blood pressure checks) and another into a central vein (for medicines).

There are certain reasons why you might not be able to join the study. For example, if you are pregnant, or if you are having specific types of surgery like brain, heart, or lung operations that require a particular breathing method. If you already have very low oxygen levels, severe long-term lung conditions like very bad COPD, or other serious lung problems, you wouldn't be able to participate. Also, if you are very overweight (BMI over 35), have certain blood disorders like sickle cell disease or thalassemia major, or if your anaesthetist thinks you might have a difficult airway, you wouldn't be eligible.

Finally, you cannot take part if you are already in another research study that involves similar treatments or checks, or if you are currently under special care where your freedom is restricted.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 16 years old or older?
Are you having a planned, non-emergency operation?
Is your anaesthetist already planning to use an arterial line and central line as part of your care?
Are you not pregnant?
Do you NOT have severe lung disease or very low usual oxygen levels?
Are you NOT scheduled for brain, heart, or specific lung surgery?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be randomly assigned to receive one of three different oxygen levels (80%, 55%, or 30%) during your general anaesthetic for your planned surgery. This oxygen would be given through the usual methods during your operation. Throughout your surgery, the research team would collect small samples from your breathing tube and take some extra blood samples from the lines that are already put in for your care. After your surgery, the team would follow up with you for up to 7 days. This follow-up would involve checking how you are recovering and may include some simple assessments. The total duration of your active participation would be up to 7 days, from your surgery day to your last follow-up check.

Potential risks and benefits

Potential benefits of taking part include helping doctors understand the best way to give oxygen during surgery, which could improve care for future patients. There's also a chance that receiving a specific oxygen level in the study might personally lead to a healthier recovery, though this isn't guaranteed. Potential risks are generally low, as all oxygen levels used are within ranges sometimes given during surgery. However, any medical procedure carries some risks, and researchers will be closely monitoring you. You always have the right to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University Hospital Southampton
Verified postcode
Southampton, United Kingdom

Common questions

What is 'general anaesthetic'?

It's medication that puts you to sleep so you don't feel pain during an operation.

Why might too much oxygen be bad?

Some studies suggest very high oxygen levels can cause stress on body cells, similar to how rust forms on metal.

Will I know which oxygen level I'm getting?

No, you will be randomly assigned to one of the three groups, and neither you nor your doctors will know which one during the surgery.

Will this affect my usual recovery from surgery?

The study aims to see if different oxygen levels affect recovery. The researchers will be carefully monitoring your progress.

Who is paying for this study?

The study is funded by the National Institute for Health and Care Research, a public body that funds health and social care research.