Does setting the breathing machine (ventilator) to deliver breaths using a method called airway pressure release ventilation help patients with diseased lungs to heal faster and spend less time on a ventilator?

Plain English summary of protocol

Background and study aims
Around half of all patients in critical care need help from a breathing machine (ventilator) to maintain oxygen levels. Although they may be life-saving, breathing machines can cause damage to diseased lungs and make chest infections more likely.
The usual way a breathing machine is used aims to protect the lungs from damage until they are healed. However, damage can still occur, and the lungs take time to recover. Airway pressure release ventilation (APRV) is a way of using the breathing machine that we think causes less damage. It moves gas into the lungs gently over a longer time. This helps to reduce lung damage, helping faster healing. APRV may reduce time on the breathing machine and in the hospital which may save costs. APRV may also reduce the risk of death.
The aim of this study is to find out if setting the breathing machine to deliver breaths using APRV helps patients with diseased lungs to heal faster and spend less time on a ventilator compared to the usual way breathing support is given in critical care. The researchers also want to know if APRV saves more lives, improves quality of life, and saves the NHS money by helping people leave CCU sooner.

Who can participate?
Patients admitted to a CCU in the UK who are:
1. Aged 18 years or more
2. Receiving support from a breathing machine
3. Have moderate to severely low oxygen levels
4. Are expected by the critical care team to stay on a breathing machine for more than 2 days

What does the study involve?
Participants will be assigned by chance (randomised) to one of two groups.
1. APRV: The breathing machine will be set to the APRV mode. APRV moves gas into the lungs gently over a longer time. APRV is available on all ventilators that are used within the NHS.
2. Usual care: The breathing machine will be set as usual by the critical care team.
There will be no other changes to care delivered by the critical care team for patients in both the APRV and usual care group.
Participants, the research team, or the critical care team will not be able to choose which group your relative/friend is in. This is decided by a computer at random, just like tossing a coin or drawing lots.
The research team will collect information about the care the participants receive while in critical care including how the breathing machine is used, how long they need the machine, and how long they stay in critical care. The research team will collect the participants’ personal information such as age, ethnicity, sex and past medical conditions before coming to critical care as this helps them to understand the effect of APRV on different groups of people.
After leaving the hospital, participants will be sent a questionnaire 2 and 6 months after hospital discharge asking about their overall wellbeing and quality of life. Each questionnaire will take about 5 to 10 minutes to complete. If needed, someone can complete them on the participant's behalf. The researchers will share the participant’s name, email address, and phone number with a third-party company in order to send them the questionnaires by text message or email. They may also get in touch with participants by text message or email if we have any queries about their questionnaire or if we have any updates related to the study.

What are the possible benefits and risks of participating?
As this is a study, participants may or may not benefit from taking part. However, the findings of the research will help to improve the treatments and care provided to patients with a similar condition now and in the future.
There is no payment for taking part in this study. However, to thank participants for their time in completing the follow-up questionnaires at 2 and 6 months, they will be given a small monetary gift voucher alongside each questionnaire.
The University of Warwick is currently leading several studies looking at how we treat patients with respiratory failure. This group of studies is called the ‘Confederation of Respiratory Critical Care Trials’ or ‘CoReCCT’. If participants are taking part in other studies within CoReCCT, they will not need to complete questionnaires for each study. Participants will only be asked to complete the questionnaires once and will receive one voucher with each questionnaire.
At this time, there are no important disadvantages or risks to taking part.

Where is the study run from?
Warwick University in partnership with NHS hospitals across the UK

When is the study starting and how long is it expected to run for?
January 2024 to August 2027

Who is funding the study?
National Institute for Health Research, Health Technology Assessment (NIHR154501) (UK)

Who is the main contact?
RELEASE trial manager, RELEASE@warwick.ac.uk

Contact information

Prof Luigi Camporota
Scientific, Principal investigator

Department of Critical Care
Guy’s & St Thomas’ NHS Foundation Trust
Westminster Bridge
London
SE1 7EH
United Kingdom

ORCID ID	0000-0001-5600-1676
Email	release@warwick.ac.uk

Prof Danny McAuley
Scientific, Principal investigator

Wellcome-Wolfson Institute for Experimental Medicine
The Queen's University of Belfast
Belfast
BT9 7BL
United Kingdom

ORCID ID	0000-0002-3283-1947
Email	release@warwick.ac.uk

Mr Jonathan Guck
Public, Scientific

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

Phone	+44 (0)2476 575 194
Email	release@warwick.ac.uk

Study information

Eligibility

Locations

Countries of recruitment

• United Kingdom
• England
• Northern Ireland
• Scotland
• Wales

Study participating centres

Results and Publications

Study outputs

Additional files

ISRCTN17158033_PROTOCOL_V2.0_13Jun24.pdf

Protocol file

ISRCTN17158033 RELEASE Study_Protocol_V3.0_26Mar2025.pdf

Protocol file

Editorial Notes

02/10/2026: The ethics approval and study participating centres were updated.
12/09/2025: Study participating centres added.
25/06/2025: The following changes were made to the trial record:
1. The ethics approval (2) was added.
2. A link to the participant information sheet was added.
3. The inclusion criteria were changed.
4. The exclusion criteria were changed.
5. The recruitment start date was changed from 03/02/2025 to 14/02/2025.
6. The study participating centres Milton Keynes University Hospital, University Hospitals Plymouth NHS Trust were added.
7. The primary outcome measure was changed.
8. The secondary outcome measures were changed.
17/06/2025: Russells Hall Hospital, Queen Elizabeth Hospital Lewisham, St Georges Hospital, Aintree University Hospital, University Hospital Lewisham, University Hospital of North Tees and William Harvey Hospital were added as study participating centres.
16/06/2025: The study participating centres Blackpool Teaching Hospitals NHS Foundation Trust, Ipswich Hospital Utc, James Cook University Hospital, Kingston Hospital, Medway NHS Foundation Trust were added.
14/03/2025: The study participating centres Arrow Park Hospital, Bedford Hospital, University Hospital Bristol, Conquest Hospital, Queen Alexandras Hospital, Tameside General Hospital were added.
17/01/2025: The following changes were made to the study record:
1. The recruitment start date was changed from 01/10/2024 to 03/02/2025.
2. The recruitment end date was changed from 31/03/2027 to 31/05/2027.
16/07/2024: The following changes were made to the study record:
1. Protocol uploaded.
2. Ethics approval details added.
3. The recruitment start date was changed from 01/08/2024 to 01/10/2024.
12/06/2024: Study's existence confirmed by the NIHR.