Awake prone positioning in non-intubated adults with respiratory failure

Plain English summary of protocol

Background and study aims
Every year, over 60,000 adults in the UK go on a ventilator on an intensive care unit. A common reason for going on a ventilator is breathing conditions, such as pneumonia. Going on a ventilator is life-saving. However, some people that go on a ventilator do unfortunately die and many patients that do survive report long-term effects on their quality of life. For this reason, avoiding the need to go on a ventilator, when safe to do so, is important to patients and the healthcare teams looking after them. We know that for patients with COVID-19, lying them on their tummy (awake prone positioning), when they require high amounts of oxygen reduces the likelihood that they will need a ventilator. We don't currently know whether this will work in patients without COVID-19. Some treatments work well in COVID-19, but not in patients requiring oxygen for conditions, such as pneumonia. We know from treating patients during the COVID-19 pandemic and feedback from patient partners that lying on your tummy can be uncomfortable. It is important that we undertake research to find out if awake prone positioning is effective in patients without COVID-19. For patients in hospital requiring high amounts of oxygen, we want to find out if lying them on their tummy, rather than lying on their back/ sitting up reduces the likelihood that they will need to go on a ventilator on an intensive care unit.

Who can participate?
Patients aged over 18 years in hospital with respiratory problems who are needing at least 40% oxygen

What does the study involve?
Participants will be randomly allocated to one of two groups. In the first group, the researchers will position patients on their front (awake prone positioning) for at least 8 hours per day for up to 5 days. In the second group, patients will receive standard care, where they will be positioned sat up in bed.
The researchers will follow up study participants for 6 months. They will record how many patients have survived and how well they have recovered using some brief questionnaires. They will also see how long people spend on intensive care units and in hospital.

What are the possible benefits and risks of participating?
During the COVID-19 pandemic, many patients in hospital received awake prone positioning. The key risks to awake prone positioning are discomfort and the possibility of dislodging medical devices (such as intravenous lines) when transferring to someone’s front.

Where is the study run from?
University of Warwick Clinical Trials Unit (UK)

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

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

Who is the main contact?
Dr Keith Couper, awakeprone@warwick.ac.uk

Contact information

Dr Keith Couper
Scientific, Principal Investigator

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

ORCID ID	0000-0003-2123-2022
Email	awakeprone@warwick.ac.uk

Miss Sharisse Alleyne
Public

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

ORCID ID	0000-0002-8026-1176
Phone	+44 (0)2476 151 343
Email	Awakeprone@warwick.ac.uk

Study information

Eligibility

Locations

Countries of recruitment

• England
• Northern Ireland
• United Kingdom
• Wales

Study participating centres

Sponsor information

University of Warwick
University/education

University House
Gibbet 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

45871_PROTOCOL_V2.0_13Jun24.pdf

45871_PIS_V2.0_11Jun24.pdf

ISRCTN63784375_PROTOCOL_V3.0_20Sep24.pdf

ISRCTN63784375_PIS_V3.0_20Sep24.pdf

ISRCTN63784375_PROTOCOL_V4.0_07Apr25.pdf

ISRCTN63784375_PIS_V4.0_31Mar25.pdf

Editorial Notes

26/06/2025: The following changes were made:
1. The following study participating centres were added: The Royal Glamorgan Hospital, St Georges Hospital, Leeds General Infirmary, University Hospital Lewisham, Watford General Hospital, Weston General Hospital, Ysbyty Glan Clwyd.
2. The United Kingdom - Wales was added to the countries of recruitment.
17/06/2025: The following changes were made:
1. Bristol Royal Infirmary, Glenfield General Hospital, Good Hope Hospital, Heartlands Hospital, Newham General Hospital, Pinderfields General Hospital, Poole Hospital, Princess Royal Hospital, Queen Elizabeth Hospital Lewisham, Queen Elizabeth Hospital, Queen Elizabeth The Queen Mother, Rotherham District General Hospital, Royal Oldham Hospital, Royal Sussex Hospital, Ulster Hospital, Warrington Hospital (site), and Weston General Hospital were added to the study participating centres.
2. Northern Ireland was added to the countries of recruitment.
16/06/2025: Bedford Hospital was added to the study participating centres.
23/05/2025: Protocol and participant information sheet were added. Secondary outcome measures updated.
14/03/2025: The study participating centres, protocol and participant information sheet were added.
22/01/2025: The recruitment start date was changed from 01/10/2024 to 03/02/2025.
09/09/2024: The recruitment start date was changed from 01/09/2024 to 01/10/2024.
01/08/2024: Study's existence confirmed by the NIHR.