RecruitingNot ApplicableInterventional

PROTECT Airways: a research study to find out if an alternative airway system is better than standard of care for patients connected to a breathing machine

The PROTECT Airways study is investigating if a new type of breathing tube is better than the standard one for patients in intensive care who need help breathing from a machine. Many patients on these machines can get serious lung infections (like pneumonia), which can make them even sicker and stay in hospital longer. This new tube is designed to reduce the risk of these infections. The study will compare it to the current tubes used in hospitals. Experts want to see if the new tube really helps patients and is good value for money across the NHS. If successful, it could improve care for many people needing breathing support in the future.

At a glance

Status

Recruiting

Phase

Not Applicable

Sponsor

University of Warwick

Enrolment target

2,194

Start

01 Mar 2025

Estimated completion

31 Dec 2028

Intensive care unit patients requiring mechanical ventilation

What is this study about?

When people are very sick and need help breathing, doctors might put a plastic tube into their windpipe and connect them to a special breathing machine called a ventilator. This often happens in intensive care units (ICU). While this treatment can save lives, a common and serious problem is getting a chest infection called ventilator-associated pneumonia (VAP). This happens when germs from your mouth and throat drip down around the tube into your lungs.

The PROTECT Airways study is looking at a new type of breathing tube that's designed to stop these infections. This new tube has special features that aim to create a better seal in the windpipe and help remove mucus, making it harder for germs to reach the lungs. Some hospitals already use this new tube and have seen good results, but experts want to make sure it works well and is a good option for all NHS hospitals across the UK. This is why a larger study is needed.

By taking part, you would be helping doctors and researchers understand if this new breathing tube truly makes a difference in preventing lung infections and improving recovery for patients on breathing machines. The goal is to find the best possible ways to care for people who are critically ill.

Key takeaways

The study compares a new breathing tube with the standard one for critically ill patients.
It aims to reduce serious lung infections in people on breathing machines.
Participation is selected at random, so you won't choose your tube type.
All other medical care will remain the same.
Information from questionnaires will be collected at 2 and 6 months after hospital discharge.
The study hopes to improve future care for patients needing breathing support.

Who may be eligible?

This study is looking for adults aged 18 or older who are in intensive care and need a breathing machine to help them breathe. You would need to be expected to stay on the breathing machine for at least 24 hours after joining the study.

You would not be able to join if doctors think you might be taken off the breathing machine within the next 24 hours. Also, if you already have a different type of breathing tube (called a tracheostomy) or have been on a breathing machine for more than 24 hours before the study team checks your eligibility, you wouldn't be able to take part.

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 18 years old or older?
Do you need a breathing machine (ventilator) in intensive care?
Are you likely to need the breathing machine for at least 24 more hours?
Have you been on a breathing machine for less than 24 hours already?
Do you not currently have a tracheostomy (a different type of breathing tube)?
Is it unlikely that your treatment will be stopped within the next 24 hours?

Answer every question to see your result.

What does participation involve?

If you join the study, you will be randomly assigned by a computer to one of two groups, like flipping a coin. You won't get to choose which group you are in, and neither will your doctors. One group will use the new, alternative breathing tube, which has features designed to maintain a better seal and remove fluids. The other group will use the standard breathing tube currently used in the hospital.

Apart from the type of breathing tube, your medical care will be exactly the same. The research team will collect information about your hospital stay, such as how long you need the breathing machine and how long you stay in hospital. They will also collect some personal details like your age and general health information. Later, about 2 and 6 months after starting the study, you'll be sent a questionnaire to ask about your general well-being and any healthcare you've used since leaving the hospital. The study will run until June 2029.

Potential risks and benefits

While you might not directly benefit from being in this study, the information gathered could help many patients needing breathing machines in the future. The new breathing tube has already been approved for use in the NHS and is used in some hospitals, so researchers don't expect it to cause any serious additional risks. However, it's important to remember that all patients who are very unwell and need a breathing machine are at risk of complications, such as lung damage or needing the tube changed or reinserted. Sadly, some very sick patients may also die. You are free to withdraw from the study at any time without it affecting your medical care.

Locations (13)

Conquest Hospital
City only
St. Leonards-on-sea, United Kingdom
Glenfield General Hospital
City only
Leicester, United Kingdom
Heartlands Hospital
Approximate
Birmingham, United Kingdom
Manchester Royal Infirmary
Approximate
Manchester, United Kingdom
Medway Maritime Hospital
Approximate
Gillingham, United Kingdom
Morriston Hospital
Unverified
Swansea, United Kingdom
Royal Oldham Hospital
Unverified
Oldham, United Kingdom
St James' s University Hospital
Unverified
Leeds, United Kingdom
University Hospital of North Tees
Unverified
Stockton-on-tees, United Kingdom
Aintree University Hospital
Unverified
Liverpool, United Kingdom
Russells Hall Hospital
Unverified
Dudley, United Kingdom
St Mary's Hospital
Unverified
London, United Kingdom

Common questions

What is the main goal of this study?

The goal is to see if a new type of breathing tube can help prevent lung infections in very ill patients on breathing machines.

Will I know which breathing tube I get?

No, a computer will randomly choose which tube you receive to ensure a fair comparison.

What happens after I leave the hospital?

You'll receive questionnaires at 2 and 6 months asking about your health and any healthcare you've used.

Is the new breathing tube safe?

Yes, it's already approved for use in the NHS, and researchers don't expect it to cause new serious risks.

Who is paying for this research?

This study is funded by the National Institute for Health Research (NIHR) in the UK.

How to find out more

PROTECT Airways Trial Manager

protectairways@warwick.ac.uk +44 (0) 2476 575 288 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.