Acute Respiratory Distress SyndromePROPOSENCT05894291
Comparaison of Two Prone Position Techniques on Occurence of Pressure Sores in ICU
A study testing Swimmer Prone Position and Prone position with arms alongside the body in people with Acute Respiratory Distress Syndrome and Pressure Ulcers Stage III, run by University Hospital, Tours at 1 site in France.
Trial summary
Acute respiratory distress syndrome (ARDS) is a diffuse inflammation of the lungs that occurs in a variety of diseases. According to the Berlin definition, ARDS is characterized by diffuse lung damage in patients with predisposing factors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome, Pressure Ulcers Stage III
- What is being tested?
- Swimmer Prone Position and Prone position with arms alongside the body
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 334 participants
- Where
- 1 siteFrance
- Study dates
- 24 Nov 2023to 22 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Intubated patient on invasive mechanical ventilation with moderate to severe acute respiratory distress syndrome according to the BERLIN classification with a P/F ratio < 150, requiring prone position.
- Express consent of the patient or representative or in the absence of this, emergency inclusion procedure
- Health insurance coverage
Who cannot join
- Patient with 2 (or more) Prone position sessions
- Patient in whom one of the two positions could not be achieved: (Joint limitation; Neck size that would prevent head rotation; Orthopaedic spinal or segmental trauma; BMI greater than 45)
- Presence of stage 2 or higher pressure ulcers on the anterior parts of the body at screening
- Presence of extracorporeal membrane oxygenation (ECMO)
- Patient already included in the study
- Pregnant or breastfeeding woman
- Patient under legal protection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation Two Different Prone Position Techniques on the Occurrence of Pressure Sores in Patients With Invasive Mechanical Ventilation With Acute Respiratory Distress Syndrome in the Intensive Care Unit : a Multicenter, Prospective Randomized Controlled Trial.
Acute respiratory distress syndrome (ARDS) is a diffuse inflammation of the lungs that occurs in a variety of diseases. According to the Berlin definition, ARDS is characterized by diffuse lung damage in patients with predisposing factors. Understanding the physiology of ARDS has led to improved ventilatory management, which must be protective to ensure adequate oxygenation and CO2 clearance. Prone position (PP) is a technique that can reduce mortality in patients with severe ARDS. PP results in a more homogeneous distribution of pulmonary stress and strain, helping to protect the lung against ventilator-induced lung injury (VILI). It also increases the PaO2/FiO2 (P/F) ratio, improves the pulmonary ventilation-perfusion ratio, decreases PaCO2 and promotes ventilation of the dorsal lung regions. This technique should be offered to all patients with severe ARDS for 16 consecutive hours, to improve survival and weaning success from mechanical ventilation. However, PP has adverse effects. A meta-analysis showed an increased risk of pressure sores, possibly linked to generalized acute inflammation associated with significant cytokine discharge and diffuse lesions of the vascular endothelium. PP also increased the risk of obstruction and displacement of the endotracheal tube. Final positioning in PP, (i.e., the position imposed on the patient for the duration of the PP session) varies from one ICU to another, and is rarely described in scientific articles. There are two main variants:
- prone , with arms alongside the body
- prone, swimmer's position
The aim of our study is to show that the "swimmer" PP reduces the occurrence of stage 3 or higher pressure sores, compared with the "arms alongside the body" PP (standard care) at Day 28 post inclusion.
- Being tested
- Swimmer Prone Position, Prone position with arms alongside the body
- Keywords
- ARDS, Pressure Sores, Pressure Ulcer, Acute Respiratory Distress Syndrome, Prone Position, Swimmer Position
- Medical subject headings
- Respiratory Distress Syndrome, Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swimmer Prone PositionOther
Patients will be positioned with the head rotated. This rotation is followed by shoulder elevation/abduction, then 90° elbow flexion for the arm opposite to the head rotation. The hand is placed flat on the bed.
A 60° to 90° flexion is performed on the hip homolateral to head rotation, combined with knee flexion.
The position is changed to the mirror position every 4 hours.
Prone position with arms alongside the bodyOther
The head will be positioned either straight or rotated to one side, depending on ICU habits. The arms are positioned symmetrically along the body, palms up. The lower limbs are positioned symmetrically and parallel, knees extended or slightly flexed if a cushion is used on the front of the feet.
Head rotation, if applicable, is performed every 4 hours.
| Study group | Role | What they receive |
|---|---|---|
| Swimmer Prone Position | Experimental | Not described Receives: Other: Swimmer Prone Position |
| Prone position with arms alongside the body | Active comparator | Not described Receives: Other: Prone position with arms alongside the body |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of stage 3 or higher pressure ulcers
Percentage of patients who acquired at least one stage 3 or 4 pressure ulcer between day 1 (randomization) and day 28 according to the revised pressure injury staging system (Edsberg, J Wound Ostomy Cont Nurs, 2016). Death and resolution of ARDS will be considered as events in competition with the occurrence of a Stage 3 or higher pressure ulcer.
Measured: Day 28 after randomization
Secondary outcomes (7)
Mortality at day 28
Mortality rate at day 28
Measured: Day 28 after randomization
In-hospital Mortality at day 90
In-hospital Mortality rate at day 90
Measured: Day 90 after randomization
Number of days without mechanical ventilation at D28
Ventilator Free days at day 28
Measured: Day 28 after randomization
Length of stay in intensive care unit (censored at Day 90)
Length of stay in intensive care unit after randomization (censored at D90)
Measured: Day 90 after randomization
Length of hospital stay (censored at D90)
Length of hospital stay after randomization (censored at D90)
Measured: Day 90 after randomization
Presence of ICU acquired weakness at discharge from ICU
Rate of patients with ICU acquired weakness defined by MRC score less than 48 at ICU discharge
Measured: Day 28 after randomization
Occurrence of scapulohumeral joint dislocation during prone period
Number of patients with at least one radiologically proven scapulohumeral dislocation during a prone position period
Measured: Day 28 after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start24 Nov 2023
- Primary completion20 Apr 2025
- Study completion22 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 334 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Collaborators
- University of New Orleans
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05894291
- Sponsor's protocol ID
- DR220257/PROPOSE
- Other IDs
- IDRCB
- Acronym
- PROPOSE
- Status last verified
- Feb 2026
- First submitted
- 30 May 2023
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.
PubMed 22797452Guerin C, Reignier J, Richard JC, Beuret P, Gacouin A, Boulain T, Mercier E, Badet M, Mercat A, Baudin O, Clavel M, Chatellier D, Jaber S, Rosselli S, Mancebo J, Sirodot M, Hilbert G, Bengler C, Richecoeur J, Gainnier M, Bayle F, Bourdin G, Leray V, Girard R, Baboi L, Ayzac L; PROSEVA Study Group. Prone positioning in severe acute respiratory distress syndrome. N Engl J Med. 2013 Jun 6;368(23):2159-68. doi: 10.1056/NEJMoa1214103. Epub 2013 May 20.
PubMed 23688302Labeau SO, Afonso E, Benbenishty J, Blackwood B, Boulanger C, Brett SJ, Calvino-Gunther S, Chaboyer W, Coyer F, Deschepper M, Francois G, Honore PM, Jankovic R, Khanna AK, Llaurado-Serra M, Lin F, Rose L, Rubulotta F, Saager L, Williams G, Blot SI; DecubICUs Study Team; European Society of Intensive Care Medicine (ESICM) Trials Group Collaborators. Prevalence, associated factors and outcomes of pressure injuries in adult intensive care unit patients: the DecubICUs study. Intensive Care Med. 2021 Feb;47(2):160-169. doi: 10.1007/s00134-020-06234-9. Epub 2020 Oct 9.
PubMed 33034686Girard R, Baboi L, Ayzac L, Richard JC, Guerin C; Proseva trial group. The impact of patient positioning on pressure ulcers in patients with severe ARDS: results from a multicentre randomised controlled trial on prone positioning. Intensive Care Med. 2014 Mar;40(3):397-403. doi: 10.1007/s00134-013-3188-1. Epub 2013 Dec 19.
PubMed 24352484Sud S, Friedrich JO, Taccone P, Polli F, Adhikari NK, Latini R, Pesenti A, Guerin C, Mancebo J, Curley MA, Fernandez R, Chan MC, Beuret P, Voggenreiter G, Sud M, Tognoni G, Gattinoni L. Prone ventilation reduces mortality in patients with acute respiratory failure and severe hypoxemia: systematic review and meta-analysis. Intensive Care Med. 2010 Apr;36(4):585-99. doi: 10.1007/s00134-009-1748-1. Epub 2010 Feb 4.
PubMed 20130832
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Two Different Prone Position Techniques on the Occurrence of Pressure Sores in Patients With Invasive Mechanical Ventilation With Acute Respiratory Distress Syndrome in the Intensive Care Unit : a Multicenter, Prospective Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05894291
- Acronym / sponsor ID
- PROPOSE / DR220257/PROPOSE
- Keywords
- ARDS, Pressure Sores, Pressure Ulcer, Acute Respiratory Distress Syndrome, Prone Position, Swimmer Position
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 334 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Collaborators
- University of New Orleans
- Study start
- 24 Nov 2023 (actual)
- Primary completion
- 20 Apr 2025 (actual)
- Study completion
- 22 May 2025 (actual)
- First posted
- 8 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acute respiratory distress syndrome (ARDS) is a diffuse inflammation of the lungs that occurs in a variety of diseases. According to the Berlin definition, ARDS is characterized by diffuse lung damage in patients with predisposing factors. Understanding the physiology of ARDS has led to improved ventilatory management, which must be protective to ensure adequate oxygenation and CO2 clearance. Prone position (PP) is a technique that can reduce mortality in patients with severe ARDS. PP results in a more homogeneous distribution of pulmonary stress and strain, helping to protect the lung against ventilator-induced lung injury (VILI). It also increases the PaO2/FiO2 (P/F) ratio, improves the pulmonary ventilation-perfusion ratio, decreases PaCO2 and promotes ventilation of the dorsal lung regions. This technique should be offered to all patients with severe ARDS for 16 consecutive hours, to improve survival and weaning success from mechanical ventilation. However, PP has adverse effects. A meta-analysis showed an increased risk of pressure sores, possibly linked to generalized acute inflammation associated with significant cytokine discharge and diffuse lesions of the vascular endothelium. PP also increased the risk of obstruction and displacement of the endotracheal tube. Final positioning in PP, (i.e., the position imposed on the patient for the duration of the PP session) varies from one ICU to another, and is rarely described in scientific articles. There are two main variants:
- prone , with arms alongside the body
- prone, swimmer's position
The aim of our study is to show that the "swimmer" PP reduces the occurrence of stage 3 or higher pressure sores, compared with the "arms alongside the body" PP (standard care) at Day 28 post inclusion.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Swimmer Prone Position | Experimental | Other: Swimmer Prone Position |
| Prone position with arms alongside the body | Active comparator | Other: Prone position with arms alongside the body |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Intubated patient on invasive mechanical ventilation with moderate to severe acute respiratory distress syndrome according to the BERLIN classification with a P/F ratio < 150, requiring prone position.
- Express consent of the patient or representative or in the absence of this, emergency inclusion procedure
- Health insurance coverage
Key exclusion criteria (7 listed)
- Patient with 2 (or more) Prone position sessions
- Patient in whom one of the two positions could not be achieved: (Joint limitation; Neck size that would prevent head rotation; Orthopaedic spinal or segmental trauma; BMI greater than 45)
- Presence of stage 2 or higher pressure ulcers on the anterior parts of the body at screening
- Presence of extracorporeal membrane oxygenation (ECMO)
- Patient already included in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Swimmer Prone PositionPatients will be positioned with the head rotated. This rotation is followed by shoulder elevation/abduction, then 90° elbow flexion for the arm opposite to the head rotation. The hand is placed flat on the bed. A 60° to 90° flexion is performed on the hip homolateral to head rotation, combined with knee flexion. The position is changed to the mirror position every 4 hours. | Other | Swimmer Prone Position |
| Prone position with arms alongside the bodyThe head will be positioned either straight or rotated to one side, depending on ICU habits. The arms are positioned symmetrically along the body, palms up. The lower limbs are positioned symmetrically and parallel, knees extended or slightly flexed if a cushion is used on the front of the feet. Head rotation, if applicable, is performed every 4 hours. | Other | Prone position with arms alongside the body |
Primary outcome
Occurrence of stage 3 or higher pressure ulcers
Time frame: Day 28 after randomization
Percentage of patients who acquired at least one stage 3 or 4 pressure ulcer between day 1 (randomization) and day 28 according to the revised pressure injury staging system (Edsberg, J Wound Ostomy Cont Nurs, 2016). Death and resolution of ARDS will be considered as events in competition with the occurrence of a Stage 3 or higher pressure ulcer.
7 secondary outcomes
Mortality at day 28
Time frame: Day 28 after randomization
In-hospital Mortality at day 90
Time frame: Day 90 after randomization
Number of days without mechanical ventilation at D28
Time frame: Day 28 after randomization
Length of stay in intensive care unit (censored at Day 90)
Time frame: Day 90 after randomization
Length of hospital stay (censored at D90)
Time frame: Day 90 after randomization
Presence of ICU acquired weakness at discharge from ICU
Time frame: Day 28 after randomization
Occurrence of scapulohumeral joint dislocation during prone period
Time frame: Day 28 after randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Background: PubMed 22797452ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.
- Background: PubMed 23688302Guerin C, Reignier J, Richard JC, Beuret P, Gacouin A, Boulain T, Mercier E, Badet M, Mercat A, Baudin O, Clavel M, Chatellier D, Jaber S, Rosselli S, Mancebo J, Sirodot M, Hilbert G, Bengler C, Richecoeur J, Gainnier M, Bayle F, Bourdin G, Leray V, Girard R, Baboi L, Ayzac L; PROSEVA Study Group. Prone positioning in severe acute respiratory distress syndrome. N Engl J Med. 2013 Jun 6;368(23):2159-68. doi: 10.1056/NEJMoa1214103. Epub 2013 May 20.
- Background: PubMed 33034686Labeau SO, Afonso E, Benbenishty J, Blackwood B, Boulanger C, Brett SJ, Calvino-Gunther S, Chaboyer W, Coyer F, Deschepper M, Francois G, Honore PM, Jankovic R, Khanna AK, Llaurado-Serra M, Lin F, Rose L, Rubulotta F, Saager L, Williams G, Blot SI; DecubICUs Study Team; European Society of Intensive Care Medicine (ESICM) Trials Group Collaborators. Prevalence, associated factors and outcomes of pressure injuries in adult intensive care unit patients: the DecubICUs study. Intensive Care Med. 2021 Feb;47(2):160-169. doi: 10.1007/s00134-020-06234-9. Epub 2020 Oct 9.
- Background: PubMed 24352484Girard R, Baboi L, Ayzac L, Richard JC, Guerin C; Proseva trial group. The impact of patient positioning on pressure ulcers in patients with severe ARDS: results from a multicentre randomised controlled trial on prone positioning. Intensive Care Med. 2014 Mar;40(3):397-403. doi: 10.1007/s00134-013-3188-1. Epub 2013 Dec 19.
- Background: PubMed 20130832Sud S, Friedrich JO, Taccone P, Polli F, Adhikari NK, Latini R, Pesenti A, Guerin C, Mancebo J, Curley MA, Fernandez R, Chan MC, Beuret P, Voggenreiter G, Sud M, Tognoni G, Gattinoni L. Prone ventilation reduces mortality in patients with acute respiratory failure and severe hypoxemia: systematic review and meta-analysis. Intensive Care Med. 2010 Apr;36(4):585-99. doi: 10.1007/s00134-009-1748-1. Epub 2010 Feb 4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Swimmer Prone Position and Prone position with arms alongside the body in people with Acute Respiratory Distress Syndrome and Pressure Ulcers Stage III, run by University Hospital, Tours at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of stage 3 or higher pressure ulcers (time frame: Day 28 after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05894291, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.