Awake prone positioning in non-intubated adults with respiratory failure
| ISRCTN | ISRCTN63784375 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63784375 |
| Integrated Research Application System (IRAS) | 335630 |
| Central Portfolio Management System (CPMS) | 62433 |
| National Institute for Health and Care Research (NIHR) | 154796 |
| Sponsor | University of Warwick |
| Funder | NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC) |
- Submission date
- 01/08/2024
- Registration date
- 20/08/2024
- Last edited
- 01/05/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Respiratory
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
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 |
|---|---|
| awakeprone@warwick.ac.uk |
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 |
| Awakeprone@warwick.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized; Interventional; Design type: Treatment, Complex Intervention, Management of Care |
| Secondary study design | Randomised controlled trial |
| Participant information sheet | 45871_PIS_V2.0_11Jun24.pdf |
| Scientific title | CoReCCT: The Awake Prone Study: Awake prone positioning in patients with acute hypoxaemic respiratory failure not due to COVID-19: A randomised controlled trial |
| Study acronym | CoReCCT |
| Study objectives | The primary objective of this trial is to evaluate the clinical effectiveness of awake prone positioning in non-intubated adults with acute hypoxaemic respiratory failure not due to COVID-19, measured by our primary outcome of tracheal intubation within 30 days. |
| Ethics approval(s) | Approved 08/07/2024, Wales REC 2 (Health and Care Research Wales, Castlebridge 5, 15-19 Cowbridge Road East, Cardiff, CF11 9AB, UK; +44 (0)2922941119, +44 (0)2922 940971, +44 (0)2922 940959; Wales.REC2@wales.nhs.uk), ref: 24/WA/0128 |
| Health condition(s) or problem(s) studied | Acute hypoxaemic respiratory failure not due to COVID-19 |
| Intervention | In the intervention arm, participants will receive awake prone positioning over a maximum of 5 days/120 hours from randomisation. The target daily duration for awake prone positioning is ≥8 hours per 24-hour period. This may be achieved through a single long period of awake prone positioning or several shorter periods. The researchers expect any shorter period to last at least 1 hour. Each day, they will record the amount of time that an individual has spent in the awake prone position (full-prone or 3/4 prone) in the preceding 24 hours. Participants will lie in a prone position as long and frequently as feasible, as soon as possible after randomisation. The intervention will continue until one of the following criteria is met: 1. 120 hours from randomisation 2. Tracheal intubation 3. Participant recovery 4. Participant decision to stop intervention 5. Development of contraindication to awake prone positioning 6. Participant transferred to a care setting where intervention could not be delivered 7. Participant transferred to another hospital In the control group, participants will receive standard care, which does not include awake prone positioning. |
| Intervention type | Other |
| Primary outcome measure(s) |
The incidence of tracheal intubation within 30 days of randomisation, measured using hospital records. This does not include tracheal intubation where it is used only to facilitate an operation or procedure. |
| Key secondary outcome measure(s) |
All secondary outcomes are measured to hospital discharge using hospital records unless specified: |
| Completion date | 31/12/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 1708 |
| Key inclusion criteria | Current inclusion criteria as of 28/07/2025: 1. Adult (age >18 years) hospitalised patient who is not intubated 2. Acute hypoxaemic respiratory failure which has required treatment with 40% oxygen or more for at least 1 hour 3. Deemed suitable for tracheal intubation in the event of physiological deterioration Previous inclusion criteria: 1. Adult (age >18 years) hospitalised patient who is not intubated 2. Acute hypoxaemic respiratory failure, defined as sustained SpO2 ≤94% whilst receiving ≥40% supplemental oxygen 3. Deemed suitable for tracheal intubation in the event of physiological deterioration |
| Key exclusion criteria | 1. Hypoxaemia fully explained by acute pulmonary oedema due to heart failure 2. Patient unwilling to attempt awake prone positioning 3. Contraindication to awake prone positioning 4. COVID-19 pneumonitis as primary cause of respiratory failure 5. Invasive mechanical ventilation during current hospital admission (except where provided only to facilitate a procedure or operation) |
| Date of first enrolment | 03/02/2025 |
| Date of final enrolment | 28/02/2027 |
Locations
Countries of recruitment
- United Kingdom
- England
- Northern Ireland
- Wales
Study participating centres
Arrowe Park Road
Wirral
CH49 5PE
England
Chesterfield Road
Calow
Chesterfield
S44 5BL
England
Bury
BL9 7TD
England
Ipswich
IP4 5PD
England
Gorleston
Great Yarmouth
NR31 6LA
England
Rothwell Road
Kettering
NN16 8UZ
England
Kingston upon Thames
KT2 7QB
England
Crewe
CW1 4QJ
England
Cwmrhydyceirw
Swansea
SA6 6NL
Wales
Cliftonville
Northampton
NN1 5BD
England
Stockport
SK2 7JE
England
Ashton-under-lyne
OL6 9RW
England
Kempston Road
Bedford
MK42 9DJ
England
Bristol
BS2 8HW
England
Leicester
LE3 9QP
England
Sutton Coldfield
B75 7RR
England
Bordesley Green
Birmingham
B9 5ST
England
London
E13 8SL
England
Wakefield
WF1 4DG
England
Poole
BH15 2JB
England
Grainger Drive
Apley
Telford
TF1 6TF
England
London
SE18 4QH
England
Edgbaston
Birmingham
B15 2GW
England
Margate
Kent
CT9 4AN
England
Rotherham
S60 2UD
England
Oldham
OL1 2JH
England
Brighton and Hove
Brighton
BN2 5BE
England
Dundonald
Belfast
BT16 1RH
Northern Ireland
Lovely Lane
Warrington
WA5 1QG
England
Pontyclun
CF72 8XR
Wales
London
SW17 0QT
England
Leeds
LS1 3EX
England
London
SE13 6LH
England
Watford
WD18 0HB
England
Uphill
Weston-super-mare
BS23 4TQ
England
Rhuddlan Road
Bodelwyddan
Rhyl
LL18 5UJ
Wales
Gloucester
GL1 3NN
England
Standing Way
Eaglestone
Milton Keynes
MK6 5LD
England
Scarborough
YO12 6QL
England
Leeds
LS9 7TF
England
Willesborough
Ashford
TN24 0LZ
England
York
YO31 8HE
England
Kempston Road
Bedford
MK42 9DJ
England
Belfast
BT9 7AB
Northern Ireland
Bristol
BS2 8HW
England
Craigavon
BT63 5QQ
Northern Ireland
Leicester
LE3 9QP
England
Great Western Road
Gloucester
GL1 3NN
England
Sutton Coldfield
B75 7RR
England
Bordesley Green
Birmingham
B9 5SS
England
Middlesbrough
TS4 3BW
England
London
SE5 9RS
England
Maidstone
ME16 9QQ
England
Gillingham
ME7 5NY
England
Standing Way
Eaglestone
Milton Keynes
MK6 5LD
England
Taunton
TA1 5DA
England
London
E13 8SL
England
Barnstaple
EX31 4JB
England
Herries Road
Sheffield
S5 7AU
England
Wakefield
WF1 4DG
England
Poole
BH15 2JB
England
Haywards Heath
RH16 4EX
England
Orpington
BR6 8ND
England
Stadium Road
London
SE18 4QH
England
Queen Elizabeth Hospital
Edgbaston
Birmingham
B15 2TH
England
Margate
CT9 4AN
England
Rotherham
S60 2UD
England
Reading
RG1 5AN
England
Blackburn
BB2 3HH
England
Pontyclun
CF72 8XR
Wales
Oldham
OL1 2JH
England
Brighton
BN2 5BE
England
Belfast
BT12 6BA
Northern Ireland
Woodlands Drive
Scarborough
YO12 6QL
England
Blackshaw Road
London
SW17 0QT
England
Leeds
LS9 7TF
England
Tonbridge Road
Pembury
Tunbridge Wells
TN2 4QJ
England
Coventry
CV2 2DX
England
London
SE13 6LH
England
Lovely Lane
Warrington
WA5 1QG
England
Watford
WD18 0HB
England
Uphill
Weston-super-mare
BS23 4TQ
England
Willesborough
Ashford
TN24 0LZ
England
York
YO31 8HE
England
Bodelwyddan
Rhyl
LL18 5UJ
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 2.0 | 11/06/2024 | 20/08/2024 | No | Yes |
| Participant information sheet | version 3.0 | 20/09/2024 | 14/03/2025 | No | Yes |
| Participant information sheet | version 4.0 | 31/03/2025 | 23/05/2025 | No | Yes |
| Protocol file | version 2.0 | 13/06/2024 | 20/08/2024 | No | No |
| Protocol file | version 3.0 | 20/09/2024 | 14/03/2025 | No | No |
| Protocol file | version 4.0 | 07/04/2025 | 23/05/2025 | No | No |
| Protocol file | version 5.0 | 03/07/2025 | 28/07/2025 | No | No |
Additional files
- 45871_PROTOCOL_V2.0_13Jun24.pdf
- Protocol file
- 45871_PIS_V2.0_11Jun24.pdf
- Participant information sheet
- ISRCTN63784375_PROTOCOL_V3.0_20Sep24.pdf
- Protocol file
- ISRCTN63784375_PIS_V3.0_20Sep24.pdf
- Participant information sheet
- ISRCTN63784375_PROTOCOL_V4.0_07Apr25.pdf
- Protocol file
- ISRCTN63784375_PIS_V4.0_31Mar25.pdf
- Participant information sheet
- ISRCTN63784375_PROTOCOL_V5.0_03Jul25.pdf
- Protocol file
Editorial Notes
01/05/2026: Study participating centres added.
12/09/2025: Study participating centres added.
28/07/2025: Protocol uploaded, inclusion criteria updated.
26/06/2025: The following changes were made:
1. The following study participating centres were added: The Royal Glamorgan Hospital, St George's 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.
