Pressure UlcerPROMESREANCT04550182
Evaluation of the Impact of the Repositioning Schedule Adapted to the Risk of Pressure Ulcer of Patients in Intensive Care Unit
A study testing Positioning schedule in people with Pressure Ulcer and Ischemic, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Pressure ulcers represent a major health issue because of their high incidence and their important consequences. There is an important risk of pressure ulcer acquisition for ICU patients with acute organ failure(s). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Ulcer, Ischemic, Ischemic Ulcer
- What is being tested?
- Positioning schedule
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,232 participants
- Where
- 1 siteFrance
- Study dates
- 22 Apr 2021to 1 Jul 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old without legal protection;
- Invasive or non-invasive mechanical ventilation;
- Inclusion in the first 48 hours following mechanical ventilation and in a maximum of 6 hours after 48 hours
- No pressure ulcer at the time of inclusion (according to EPUAP);
- Hospitalized in intensive care for less than 72 hours;
- Consent signed by the patient or in the event of the patient's temporary inability to express his or her wishes, consent will be obtained from a relative and signed by the patient as soon as possible; or in the absence of a relative, an emergency inclusion may be made; in this case a consent to proceed must be signed by the patient as soon as possible.
Who cannot join
- Patient admitted to intensive care unit for the multiple trauma management with spinal cord injury;
- Patient concerned by a medical decision to withhold/withdraw life sustaining therapies at the time of potential inclusion.
- Patient recruited in any other interventional research studying mobilization or positioning of the patient and/or pressure ulcer prevention and/or being in exclusion period of any other research if concerned;
- Patient already included once in the study
- Person without any health insurance scheme or not benefiting from a social security scheme
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Réanimation Médico-chirurgicale. Hôpital Tenon, AP-HP
Paris, Île-de-France Region, 75020
About this study
Pressure ulcers represent a major health issue because of their high incidence and their important consequences. There is an important risk of pressure ulcer acquisition for ICU patients with acute organ failure(s).
Specific risk factors identified in ICU are immobility, which accentuates the effects of friction and shears, as well as mechanical ventilation and the use of vasopressors.
Read more
A repositioning schedule is a guideline for pressure ulcer prevention, but repositioning frequency remains unknown.
Adaptation of the repositioning schedule to pressure ulcer risk assessment using Braden scale should decrease the emergence of pressure ulcer. This could limit their important consequences for ICU patients which add to their brittle clinical condition (infection, increased length of stay, mortality…).
Read the detailed description
This is a multicenter randomized controlled cluster, parallel open study. In order to avoid a contamination bias between groups, this trial will be randomized at the center level. This randomization will lead to the formation of 2 groups: a group of control centers (usual care) and a group of interventional centers (repositioning schedule).
A visit to set up the study will be carried out before the beginning of the inclusions. During this visit, a training course will be delivered to the caregivers of all the research centers on the risk assessment of pressure ulcers using the Braden scale, the evaluation of the skin condition, the identification of the stages of pressure and their management as well as the collection of data necessary for this study. In addition, the interventional group centers will receive training on the application of the repositioning schedule.
The risk assessment for pressure ulcers using the Braden scale will be performed daily in both groups. All patients participating in research with a Braden scale ≤ 17 will benefit from a pressure ulcer prevention mattress.
Usual care:
Within the control group, repositioning schedule frequencies and positioning will be done according to the habits of the service. The daily collection form present in the room will collect information concerning the care related to the positioning of the patient (length of treatment, frequency of positioning, type of positioning, any adverse events occurring during this care), the evaluation of the patients 'cutaneous status, duration of pressure ulcer care and evaluation of the Braden scale. The possible contraindications to the positioning of the patients will be informed by the doctors on the medical prescription according to the current practice.
Repositioning schedule:
Within the interventional group the repositioning schedule will be applied according to the risk of pressure ulcer evaluated daily by the Braden scale. A medical prescription, as part of the care, will attest to the absence of absolute contraindication or relative to the procedure of mobilization.
Depending on the result of the Braden scale, the repositioning schedule is defined as follows:
6 ≥ Braden ≤ 8: alternate positioning every 2 hours; 9 ≥Braden ≤ 13: alternate positioning every 4 hours; 14 ≥ Braden ≤ 17: No alternative of the positioning required, but a friction and an evaluation of the cutaneous state every 6 hours.
18 ≥Braden ≤ 23: No alternative of the positioning required, but a friction and an evaluation of the cutaneous state every 12 hours
- Conditions
- Pressure Ulcer, Ischemic, Ischemic Ulcer
- Being tested
- Positioning schedule
- Keywords
- Intensive care unit, ICU, adult critical care patients, repositioning schedule, patient handling, practical nursing, nursing care, pressure ulcers, decubitus ulcers, pressure injury
- Medical subject headings
- Pressure Ulcer, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positioning scheduleProcedure or surgery
Also called Positioning, prevention of pressure ulcers, repositioning program
The Braden scale will be collected every morning. Patients' care will be friction and repositioning applied at a frequency defined by the Braden scale:
6 ≥ Braden ≤ 8: alternate positioning every 2 hours 9 ≥Braden ≤ 13: alternate positioning every 4 hours 14 ≥ Braden ≤ 17: No alternative of the positioning required, but a friction and an evaluation of the cutaneous state every 6 hours.
18 ≥Braden ≤ 23: No alternative of the positioning required, but a friction and an evaluation of the cutaneous state every 12 hours.
Positioning will alternate semi-lateral decubitus at 30, semi-Fowler 30° -30°, half-sitting position 45° with elevation of the lower limbs.
A medical prescription as part of the daily reassessed care will ensure the absence of absolute contraindication to the mobilization or contraindication to certain positions.Friction will be performed during repositioning.
| Study group | Role | What they receive |
|---|---|---|
| Individual positioning schedule | Experimental | Pressure ulcer prevention cares are provided according to the positioning schedule for every patient. Receives: Procedure: Positioning schedule |
| Standard care | No intervention | Pressure ulcer prevention cares are provided according to usual practice of the ICU. Frequency and modality of positioning applied to the patients are collected. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of pressure ulcer at day 28
To assess the efficacy of a positioning schedule whose frequency of positioning is adapted every day to pressure ulcer risk assessed by the Braden scale and to the clinical state of the patient in adult ICUs, compared to usual PU prevention management (without schedule daily adapted to PU risk) at the 28th day, or when leaving ICU, or at death if it occurs before.
Efficacy of the procedure will be measured by the proportion of pressure ulcer at day 28 or at ICU discharge or death if it occurs before.
Measured: Up to 28 days
Secondary outcomes (8)
Tolerance of a repositioning schedule in adult intensive care unit
Tolerance of the procedure will be appreciated by the proportion of adverse events that occurred during repositioning.
The adverse events are:
- accidental removal of invasive devices (intubation probe, catheter, drain, gastric tube, urinary catheter);
- the occurrence of hemodynamic or respiratory instability ( Heart rate <40 or > 130 / min, Systolic Blood Pressure <90 mmHg, oxygen saturation <90%) necessitating stopping repositioning.
Measured: Up to 28 days
Impact of repositioning schedule on the length of hospitalization in intensive care unit
Length of intensive care unit stay
Measured: Up to 28 days
Evaluate the applicability of a repositioning schedule and clinical barriers to patients' repositioning schedule
Analysis of the correlation between the realization of the repositioning schedule and the characteristics of the patients, the SOFA and SAPS2 scores, the administration of support therapies (mechanical ventilation, vasoactive drugs, renal replacement therapy purification, ECCO2R, ECMO) and the medical and paramedical contraindications provided by caregivers and physicians on the daily collection form.
Measured: Up to 28 days
Risk factors for pressure ulcer on critically ill patients
Identify the factors leading to the development of a pressure ulcer by completing a daily collection form.
Measured: Up to 28 days
Impact of a repositioning schedule on the time spent caring for alternate position procedure prevention in adult intensive care units
Care time dedicated to the prevention in adult ICU evaluated by the positioning times in the care of positioning reported on the daily collection form.
Measured: Up to 28 days
Impact of a repositioning schedule on the management of bedsores in adult intensive care units
Management of pressure ulcers in adult ICU evaluated by the number of caregivers involved in the care of positioning reported on the daily collection form.
Measured: Up to 28 days
Impact of a repositioning schedule on invasive care therapy for pressure ulcers
Proportion of pressure ulcers requiring one of the following: surgical intervention, negative pressure wound therapy (VAC), antibiotic treatment;
Measured: Up to 28 days
total cost of the procedure and cost per pressure ulcer avoided
Impact of the repositioning schedule on hospital costs and the occurrence of pressure ulcers will be compared through cost-effectiveness analysis and budget impact analysis. We will perform an analysis for staff cost and an analysis for the hospital cost per patient.
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start22 Apr 2021
- Primary completion1 Jul 2024
- Study completion1 Jul 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.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Model description
- To assess efficacy of a positioning schedule whose frequency of positioning is adapted every day to pressure ulcer risk assessed by Braden scale on the occurrence of pressure ulcer in adult ICUs, in comparison with the routine patients' management (without positioning schedule adapted on PU risk) at the 28th day, or when leaving ICU, or at death if it occurs before.
- Masking
- None (open label)
- Enrolment
- 1,232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daisy Mehay, Degree Nurse in intensive care, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04550182
- Sponsor's protocol ID
- APHP180674
- Other IDs
- 2019-A02287-50
- Acronym
- PROMESREA
- Status last verified
- Feb 2025
- First submitted
- 6 Jan 2020
- Last updated
- 6 Feb 2025
- 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 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of the Repositioning Schedule Adapted to the Risk of Pressure Ulcer of Patients in Intensive Care Unit
- ClinicalTrials.gov ID
- NCT04550182
- Acronym / sponsor ID
- PROMESREA / APHP180674
- Conditions
- Pressure Ulcer, Ischemic, Ischemic Ulcer
- Keywords
- Intensive care unit, ICU, adult critical care patients, repositioning schedule, patient handling, practical nursing, nursing care, pressure ulcers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,232 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 22 Apr 2021 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 16 Sep 2020 (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.
Pressure ulcers represent a major health issue because of their high incidence and their important consequences. There is an important risk of pressure ulcer acquisition for ICU patients with acute organ failure(s).
Specific risk factors identified in ICU are immobility, which accentuates the effects of friction and shears, as well as mechanical ventilation and the use of vasopressors.
A repositioning schedule is a guideline for pressure ulcer prevention, but repositioning frequency remains unknown.
Adaptation of the repositioning schedule to pressure ulcer risk assessment using Braden scale should decrease the emergence of pressure ulcer. This could limit their important consequences for ICU patients which add to their brittle clinical condition (infection, increased length of stay, mortality…).
Detailed description
This is a multicenter randomized controlled cluster, parallel open study. In order to avoid a contamination bias between groups, this trial will be randomized at the center level. This randomization will lead to the formation of 2 groups: a group of control centers (usual care) and a group of interventional centers (repositioning schedule).
A visit to set up the study will be carried out before the beginning of the inclusions. During this visit, a training course will be delivered to the caregivers of all the research centers on the risk assessment of pressure ulcers using the Braden scale, the evaluation of the skin condition, the identification of the stages of pressure and their management as well as the collection of data necessary for this study. In addition, the interventional group centers will receive training on the application of the repositioning schedule.
The risk assessment for pressure ulcers using the Braden scale will be performed daily in both groups. All patients participating in research with a Braden scale ≤ 17 will benefit from a pressure ulcer prevention mattress.
Usual care:
Within the control group, repositioning schedule frequencies and positioning will be done according to the habits of the service. The daily collection form present in the room will collect information concerning the care related to the positioning of the patient (length of treatment, frequency of positioning, type of positioning, any adverse events occurring during this care), the evaluation of the patients 'cutaneous status, duration of pressure ulcer care and evaluation of the Braden scale. The possible contraindications to the positioning of the patients will be informed by the doctors on the medical prescription according to the current practice.
Repositioning schedule:
Within the interventional group the repositioning schedule will be applied according to the risk of pressure ulcer evaluated daily by the Braden scale. A medical prescription, as part of the care, will attest to the absence of absolute contraindication or relative to the procedure of mobilization.
Depending on the result of the Braden scale, the repositioning schedule is defined as follows:
6 ≥ Braden ≤ 8: alternate positioning every 2 hours; 9 ≥Braden ≤ 13: alternate positioning every 4 hours; 14 ≥ Braden ≤ 17: No alternative of the positioning required, but a friction and an evaluation of the cutaneous state every 6 hours.
18 ≥Braden ≤ 23: No alternative of the positioning required, but a friction and an evaluation of the cutaneous state every 12 hours
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- To assess efficacy of a positioning schedule whose frequency of positioning is adapted every day to pressure ulcer risk assessed by Braden scale on the occurrence of pressure ulcer in adult ICUs, in comparison with the routine patients' management (without positioning schedule adapted on PU risk) at the 28th day, or when leaving ICU, or at death if it occurs before.
| Arm | Type | Receives |
|---|---|---|
| Individual positioning schedule | Experimental | Procedure: Positioning schedulePressure ulcer prevention cares are provided according to the positioning schedule for every patient. |
| Standard care | No intervention | –Pressure ulcer prevention cares are provided according to usual practice of the ICU. Frequency and modality of positioning applied to the patients are collected. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years old without legal protection;
- Invasive or non-invasive mechanical ventilation;
- Inclusion in the first 48 hours following mechanical ventilation and in a maximum of 6 hours after 48 hours
- No pressure ulcer at the time of inclusion (according to EPUAP);
- Hospitalized in intensive care for less than 72 hours;
Key exclusion criteria (5 listed)
- Patient admitted to intensive care unit for the multiple trauma management with spinal cord injury;
- Patient concerned by a medical decision to withhold/withdraw life sustaining therapies at the time of potential inclusion.
- Patient recruited in any other interventional research studying mobilization or positioning of the patient and/or pressure ulcer prevention and/or being in exclusion period of any other research if concerned;
- Patient already included once in the study
- Person without any health insurance scheme or not benefiting from a social security scheme
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 |
|---|---|---|
| Positioning scheduleAlso: Positioning, prevention of pressure ulcers, repositioning programThe Braden scale will be collected every morning. Patients' care will be friction and repositioning applied at a frequency defined by the Braden scale: 6 ≥ Braden ≤ 8: alternate positioning every 2 hours 9 ≥Braden ≤ 13: alternate positioning every 4 hours 14 ≥ Braden ≤ 17: No alternative of the positioning required, but a friction and an evaluation of the cutaneous state every 6 hours. 18 ≥Braden ≤ 23: No alternative of the positioning required, but a friction and an evaluation of the cutaneous state every 12 hours. Positioning will alternate semi-lateral decubitus at 30, semi-Fowler 30° -30°, half-sitting position 45° with elevation of the lower limbs. A medical prescription as part of the daily reassessed care will ensure the absence of absolute contraindication to the mobilization or contraindication to certain positions.Friction will be performed during repositioning. | Procedure or surgery | Individual positioning schedule |
Primary outcome
The proportion of pressure ulcer at day 28
Time frame: Up to 28 days
To assess the efficacy of a positioning schedule whose frequency of positioning is adapted every day to pressure ulcer risk assessed by the Braden scale and to the clinical state of the patient in adult ICUs, compared to usual PU prevention management (without schedule daily adapted to PU risk) at the 28th day, or when leaving ICU, or at death if it occurs before. Efficacy of the procedure will be measured by the proportion of pressure ulcer at day 28 or at ICU discharge or death if it occurs before.
8 secondary outcomes
Tolerance of a repositioning schedule in adult intensive care unit
Time frame: Up to 28 days
Impact of repositioning schedule on the length of hospitalization in intensive care unit
Time frame: Up to 28 days
Evaluate the applicability of a repositioning schedule and clinical barriers to patients' repositioning schedule
Time frame: Up to 28 days
Risk factors for pressure ulcer on critically ill patients
Time frame: Up to 28 days
Impact of a repositioning schedule on the time spent caring for alternate position procedure prevention in adult intensive care units
Time frame: Up to 28 days
Impact of a repositioning schedule on the management of bedsores in adult intensive care units
Time frame: Up to 28 days
Impact of a repositioning schedule on invasive care therapy for pressure ulcers
Time frame: Up to 28 days
total cost of the procedure and cost per pressure ulcer avoided
Time frame: Up to 28 days
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 6 Feb 2025.
- 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.
Daisy Mehay, Degree Nurse in intensive care principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positioning schedule in people with Pressure Ulcer and Ischemic, run by Assistance Publique - Hôpitaux de Paris 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 6 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 6 Feb 2025. 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?
The proportion of pressure ulcer at day 28 (time frame: Up to 28 days). 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 6 Feb 2025.