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

Plain English summary of protocol

Background and study aims
A breathing tube is the pathway through which air flows into the lungs. Intensive care units (ICU) are specialist hospital wards that provide treatment and monitoring for people who are very ill. Close to 184,000 patients annually are admitted to NHS ICUs and 33% require help with their breathing, using a machine which is called invasive mechanical ventilation. Treatment involves placing a plastic tube through the mouth into the windpipe and attaching the person to a breathing machine (ventilator). A serious complication of this life-saving treatment is a chest infection or ventilator-associated pneumonia (VAP) which affects 20% of people on ventilators. It occurs when mucus, a jelly-like liquid that lines your lungs, throat, mouth, nose, that is infected drips down the back of the throat past the plastic tube into the lungs. Whilst VAP can be treated with antibiotics, some people will die and others will spend much longer on a ventilator.
The alternative airway system aims to improve the windpipe seal and reduce the risk of infected mucus passing down into the lung, by maintaining the inflation of the protective cuff. Patient studies suggest this system is safe and effective at removing mucus and preventing lung infection. Some hospitals are using the alternative airway system. However, we do not know if the positive findings seen in a few hospitals would also be seen in the wider NHS, and whether the new tube is good value for money, resulting in benefits to patients. The National Institute for Health and Care Excellence (NICE), the organisation that provides guidance for health and care practitioners to deliver the best care, has therefore recommended a large-scale research study to see if this equipment is needed.

Who can participate?
Adult (aged 18 years and over), needing invasive mechanical ventilation, likely to remain on a breathing machine for at least 24 hours following study entry.

What does the study involve?
Participants will be assigned by chance (known as randomisation) to one of two groups:
1. Alternative airway system: This is similar to the standard care tube, and in addition has a system to ensure the seal to the patient is maintained and has multiple ports to remove secretions (fluids).
2. Standard care: The tube usually used by the hospital will be used.
There will be no other changes to care given to patients in both the alternative airway system and the standard care group.
The participant and the hospital team will not be able to choose which group they are placed in. This is decided by a computer at random (known as randomisation). This process ensures there is an equal chance of being placed in either group and is the best way to ensure that there is a fair comparison between both tubes.
The research team will collect information about care the participant receives while in hospital including how the ventilator is used, how long they need the ventilator, and how long they stay in hospital. The research team will collect personal information such as age, ethnicity, sex and past medical conditions before coming to critical care as this helps to understand the effect of the tube on different groups of people.
The participant will be sent a questionnaire 2 and 6 months after entering the study asking about overall wellbeing and any healthcare used.

What are the possible benefits and risks of participating?
As this is a research study, the participant may or may not experience a direct benefit. However, the findings of the study may help people needing a breathing machine in critical care in the future.
The alternative airway system is approved for use in the NHS and is already used as part of standard care in some hospitals. Therefore, the researchers do not anticipate any serious risk specific to being in the alternative airway system group. However, all patients who are very sick and need a breathing machine are at risk of complications such as damage to the lungs or needing the tube to be put back in after it is removed due to ongoing problems with breathing. Some very sick patients may even die.

Where is the study run from?
The study is sponsored by the University of Warwick and is coordinated by the Warwick Clinical Trials Unit in partnership with NHS hospitals across the UK

When is the study starting and how long is it expected to run for?
May 2024 to June 2029

Who is funding the study?
The National Institute for Health Research, Health Technology Assessment (NIHR156500) (UK)

Who is the main contact?
PROTECT Airways Trial Manager, protectairways@warwick.ac.uk

Contact information

Dr Gareth Kitchen
Scientific

University of Manchester
Oxford Road
Manchester
M13 9PL
United Kingdom

ORCID ID	0000-0001-5070-3183
Email	protectairways@warwick.ac.uk

Prof Paul Dark
Scientific

University of Manchester
Oxford Road
Manchester
M13 9PL
United Kingdom

ORCID ID	0000-0003-3309-0164
Email	protectairways@warwick.ac.uk

Dr PROTECT Airways Trial Manager
Public

Warwick Clinical Trials Unit
Warwick Medical School
University of Warwick
Gibbet Hill Road
Coventry
CV4 7AL
United Kingdom

Phone	+44 (0) 2476 575 288
Email	protectairways@warwick.ac.uk

Study information

Eligibility

Locations

Countries of recruitment

• England
• United Kingdom

Study participating centres

Sponsor information

University of Warwick
University/education

University House
Gibbett Hill Road
Coventry
CV4 7AL
England
United Kingdom

Phone	+44 (0)2476575733
Email	sponsorship@warwick.ac.uk
Website	http://www2.warwick.ac.uk/
"ROR"	https://ror.org/01a77tt86

Funders

Funder type

Government

Results and Publications

Study outputs

Additional files

46879_PIS_V1.0.pdf

Editorial Notes

21/02/2025: Study's existence confirmed by the NIHR.