Pressure UlcerHEALTHY-PRONENCT06025370
Pressures During Prone Positions in Healthy Volunteers
A study testing Prone Position in people with Pressure Ulcer, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
Trial summary
Prone positioning (PP) reduces mortality in the most severe cases of acute respiratory distress syndrome (ARDS). Despite the benefits of PP, this technique presents adverse effects such as an increased risk of bedsores, linked to the duration, which must be around 16 consecutive hours. There are 2 PP techniques: 1. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pressure Ulcer
- What is being tested?
- Prone Position
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 4 Oct 2023to 4 Jan 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female
- Major volunteer
Who cannot join
- Volunteers with cervical mobility problems preventing them from rotating their head 90°
- Volunteers with scapulohumeral joint mobility problems preventing them from performing 90° elevation/abduction.
- Pregnant volunteer (confirmed by a blood sample test or a positive pregnancy test).
- Volunteer not affiliated to a French social security system
- Volunteer protected by law
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier Régional d'Orléans
Orléans, Centre-Val de Loire, 45067
About this study
Official title: Measurement of Pressures Generated During Different Prone Positions in Healthy Volunteers
Prone positioning (PP) reduces mortality in the most severe cases of acute respiratory distress syndrome (ARDS). Despite the benefits of PP, this technique presents adverse effects such as an increased risk of bedsores, linked to the duration, which must be around 16 consecutive hours.
There are 2 PP techniques:
Read more
- Positioning with arms alongside the body
- Swimmer's position At present, no study compares or has compared prospectively, the impact of the type of position used during ventral decubitus on mortality and the incidence of pressure sores, nor on secondary effects in intensive care.
Pressure transducers are available for instantaneous measurement of pressures between 2 interfaces. The investigators have acquired a pressure-measuring device, a mattress topper which is attached to the resuscitation mattress and which, connected to a PC, provides a live display of the pressures between the patient and the mattress.
The investigators would like to use their device to measure pressures during these 2 PP in healthy volunteers, which would enable them to obtain the world's first data on the real pressures generated during PP.
- Conditions
- Pressure Ulcer
- Being tested
- Prone Position
- Keywords
- Healthy Volunteer, Pressure Mapping, ARDS, Prone Position
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prone PositionOther
All healthy volunteers will be positioned in prone position, on a bed equipped with a mapping pressure system.
The volunteers will spend 5 minutes in each of the positions corresponding to the study groups.
| Study group | Role | What they receive |
|---|---|---|
| Swimmer Position | Experimental | Not described Receives: Other: Prone Position |
| Arms at side | Active comparator | Not described Receives: Other: Prone Position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin/Bed pressures
Obtain pressure values for both prone position techniques on pressure sore risk zones (face/shoulders/hips/knees/feet)
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start4 Oct 2023
- Primary completion4 Oct 2023
- Study completion4 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure UlcerStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume FOSSAT, Msc, Principal investigator, CHU ORLEANS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06025370
- Sponsor's protocol ID
- CHRO-2022-13
- Acronym
- HEALTHY-PRONE
- Status last verified
- Jan 2024
- First submitted
- 29 Aug 2023
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Pressures Generated During Different Prone Positions in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06025370
- Acronym / sponsor ID
- HEALTHY-PRONE / CHRO-2022-13
- Conditions
- Pressure Ulcer
- Keywords
- Healthy Volunteer, Pressure Mapping, ARDS, Prone Position
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 4 Oct 2023 (actual)
- Primary completion
- 4 Oct 2023 (actual)
- Study completion
- 4 Jan 2024 (actual)
- First posted
- 6 Sep 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.
Prone positioning (PP) reduces mortality in the most severe cases of acute respiratory distress syndrome (ARDS). Despite the benefits of PP, this technique presents adverse effects such as an increased risk of bedsores, linked to the duration, which must be around 16 consecutive hours.
There are 2 PP techniques:
- Positioning with arms alongside the body
- Swimmer's position At present, no study compares or has compared prospectively, the impact of the type of position used during ventral decubitus on mortality and the incidence of pressure sores, nor on secondary effects in intensive care.
Pressure transducers are available for instantaneous measurement of pressures between 2 interfaces. The investigators have acquired a pressure-measuring device, a mattress topper which is attached to the resuscitation mattress and which, connected to a PC, provides a live display of the pressures between the patient and the mattress.
The investigators would like to use their device to measure pressures during these 2 PP in healthy volunteers, which would enable them to obtain the world's first data on the real pressures generated during PP.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Swimmer Position | Experimental | Other: Prone Position |
| Arms at side | Active comparator | Other: Prone Position |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female
- Major volunteer
Key exclusion criteria (5 listed)
- Volunteers with cervical mobility problems preventing them from rotating their head 90°
- Volunteers with scapulohumeral joint mobility problems preventing them from performing 90° elevation/abduction.
- Pregnant volunteer (confirmed by a blood sample test or a positive pregnancy test).
- Volunteer not affiliated to a French social security system
- Volunteer protected by law
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 |
|---|---|---|
| Prone PositionAll healthy volunteers will be positioned in prone position, on a bed equipped with a mapping pressure system. The volunteers will spend 5 minutes in each of the positions corresponding to the study groups. | Other | Arms at side, Swimmer Position |
Primary outcome
Skin/Bed pressures
Time frame: 5 minutes
Obtain pressure values for both prone position techniques on pressure sore risk zones (face/shoulders/hips/knees/feet)
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 17 Jan 2024.
- 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.
Guillaume FOSSAT, Msc principal investigator
CHU ORLEANS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prone Position in people with Pressure Ulcer, run by Centre Hospitalier Régional d'Orléans 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 2 inclusion and 5 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 17 Jan 2024. 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?
Skin/Bed pressures (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jan 2024.