Pressure UlcersPROMESReaPilotNCT03454230
Pilot Study for Evaluation of the Procedure Impact of Mobilization Adapted to Pressure Ulcer Risk for Patients in Intensive Care.
A study testing Positioning schedule in people with Pressure Ulcers and Nursing Cares, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Pressure ulcers (PU) represent a major health issue because of their high incidence and of their important consequences. There is an important risk of pressure ulcer acquisition for ICU patient with acute organ failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Ulcers, Nursing Cares, Decubitus 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
- 36 participants
- Where
- 1 siteFrance
- Study dates
- 5 Mar 2018to 30 Oct 2018
- 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
- Expected duration of invasive ventilation: more than 24 hours at inclusion;
- No pressure ulcer at inclusion (using of a tool developed from the European Pressure Ulcer Advisory Panel);;
- Information of the patient, or if it is not possible information of his relatives, or emergency procedure if contacting relatives is not possible. Consent document will then be signed by the patient as soon as he is able to do.
Who cannot join
- Under than 18 years;
- Pregnant woman;
- protected adult as defined by the law;
- Person without any health insurance;
- 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 admitted in ICU for the multiple trauma management;
- patient concerned by a medical decision to limit active therapies at the time of potential inclusion.
Trial locations and contacts
1 site in 1 country.
About this study
Pressure ulcers (PU) represent a major health issue because of their high incidence and of their important consequences. There is an important risk of pressure ulcer acquisition for ICU patient with acute organ failure.
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 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 study will assess feasibility, efficacy and tolerance of a repositioning schedule applied to ICU adult patients. The repositioning schedule will be daily adapted to pressure ulcer risk of the patient assessed with Braden scale.
If results of this pilot study show improvement by the application of the repositioning schedule, they will argue the realization of a multicenter randomized clinical trial. This larger study will assess the expected decrease of pressure ulcers incidence due to the schedule and of its benefit-risk ratio.
This is a one-center prospective pilot study which includes two one-month consequential periods:
- During the first period, care will be delivered according usual practice. It is an observational phase.
- The second period will begin with medical and nurse staff training. Then, care will be delivered according the repositioning schedule. It's an interventional phase.
The procedure will be prescribed every day on patient's prescription by the doctor in charge (that will be filed with medical record).
- During the two periods: Every morning, inclusion and non-inclusion criteria will be sought for every patient intubated for at least 24 hours. This evaluation will be made by a nurse during daily medical staff meeting.
Eligible patients will be informed. Their consent will be collected and they will be included in the study. Patient characteristics (age, gender, BMI, simplified acute physiology score SAPS II, Sequential Organ Failure Assessment (SOFA) Score, length of mechanical ventilation, length of stay and mortality in ICU) will be taken from the PMSI. Those data are usually daily collected.
During the second period: data about Braden scale, positioning schedule, different positions applied, possible adverse events during positioning and presence of pressure ulcer will be collected by caregivers and nurses caring the patient.
Those data will be collected on the "daily positioning sheet" made available in patient's room. Skin condition will be evaluated on the 28th day, or when leaving ICU wall, or at death if it occurs before. Clinical research technician will control concordance between repositioning data and position applied by caregivers and nurses and those recommended by the schedule.
- Conditions
- Pressure Ulcers, Nursing Cares, Decubitus Ulcer, Pressure Injury
- 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
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
Applying repositioning schedule daily adapted to pressure ulcer risk assessed with Braden scale. Then, the nurse will applied oil for PU prevention and repositioning which frequency will be defined by the Braden score. The positions will be the semi-fowler 30-30, the half-sitting position with a 45° angle position and patient lying on their back with the head up with a 30° angle for ventilator associated pneumonia prevention.
Repositioning schedule will be applied according to the daily medical prescription. When physician allows to sit the patient on a chair, this have to be done by raising feet on a stool. Therefore, patients will stay in that chair as long as defined by positioning schedule. When patient is returned to bed, same positions as described above will be used alternately. In the time of positioning care, oil usually used for PU prevention will be applied on the skin of the areas of high risk of PU (heels, sacrum, elbows, trochanter, knees) and bone projections.
| Study group | Role | What they receive |
|---|---|---|
| Positioning schedule | Experimental | Applying repositioning schedule daily adapted to pressure ulcer risk assessed with Braden scale. Then, the nurse will applied oil for PU prevention and repositioning which frequency will be defined by the Braden score. The positions will be the semi-fowler 30-30, the half-sitting position with a 45° angle position and patient lying on their back with the head up with a 30° angle for ventilator associated pneumonia prevention.
Repositioning schedule will be applied according to the daily medical prescription. When physician allows to sit the patient on a chair, this have to be done by raising feet on a stool. Therefore, patients will stay in that chair as long as defined by positioning schedule. When patient is returned to bed, same positions as described above will be used alternately. In the time of positioning care, oil usually used for PU prevention will be applied on the skin of the areas of high risk of PU (heels, sacrum, elbows, trochanter, knees) and bone projections. Receives: Procedure: Positioning schedule |
| Common repositioning practice | No intervention | pressure ulcer prevention cares are provided according to usual practice. 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.
positioning schedule efficacy
To assess efficacy of a positioning schedule whose frequency of positioning is adapted every day to pressure ulcer risk assessed by Braden scale in adult ICU, compared to usual PU prevention management (without schedule daily adapted to PU risk) at the 28th day, or when leaving ICU wall, or at death if it occurs before.
Measured: 28 days
Secondary outcomes (4)
Caregivers commitment to the standardized positioning schedule in adult ICU (1)
Nurses commitment will be evaluated by accordance between frequency of positioning (mobilization frequency per day) according to the schedule and the frequency of positioning actually carried out by caregivers,
These data will be collected by nurses on the "daily positioning sheet" made available in patient's room.
Measured: 28 days
Caregivers commitment to the standardized positioning schedule in adult ICU (2)
Nurses commitment will be evaluated, by accordance between the positions planned by the schedule (Right Semi-Lateral Decubitus, Left Semi-Lateral Decubitus, Semi-Fowler 30 °, Half-Seated 45 °, Seated in Armchair) and those actually achieved by caregivers.
These data will be collected by nurses on the "daily positioning sheet" made available in patient's room.
Measured: 28 days
nursing workload
To assess the workload added to nursing care by the positioning schedule : nursing workload will be assessed by the total time dedicated for positioning the patient. This time will be calculated in minutes, from positioning time notified on the "daily positioning sheet". It will be reported on the "positioning sheet stay" by the clinical research technician.
Measured: 28 days
clinical safety of the positioning schedule
To assess the clinical safety of the positioning schedule : the clinical safety will be assessed by the percentage of adverse events occurrence during when positioning the patients.
Adverse events are defined as accidental removal of invasive devices (breathing tube, catheter, chest tube, gastric tube, urinary catheter) and an instability (hemodynamic or respiratory) requiring positioning discontinuation. Caregivers monitor vital parameters during positioning and discontinue the positioning if hemodynamic or respiratory instability occurs, according to nurse's clinical evaluation. Adverse events will be notified on the "daily positioning sheet" and on the "positioning sheet stay" by caregivers charge positioning the patient.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2018
- Study start5 Mar 2018
- Primary completion13 Sep 2018
- Study completion30 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure UlcersStudies 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
- Non-randomised
- Intervention model
- Sequential
- 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 occurrence of pressure ulcer in adult ICU in comparison with the routine patient management (without positioning schedule adapted on PU risk) at the 28th day, or when leaving ICU wall, or at death if it occurs before.
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MEHAY Daisy, RN, Principal investigator, Service de réanimation médico chirurgicale, Hôpital Tenon (AP-HP), ParisFARTOUKH Muriel, MD, Study director, Service de réanimation médico chirurgicale, Hôpital Tenon (AP-HP), Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03454230
- Sponsor's protocol ID
- K171008J
- Other IDs
- 2017-A03038-45
- Acronym
- PROMESReaPilot
- Status last verified
- Nov 2018
- First submitted
- 26 Feb 2018
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is planned to share data to argue the realization of a multicenter trial on this theme. This data can be shared by different way including e-mail transfer.
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study for Evaluation of the Procedure Impact of Mobilization Adapted to Pressure Ulcer Risk for Patients in Intensive Care.
- ClinicalTrials.gov ID
- NCT03454230
- Acronym / sponsor ID
- PROMESReaPilot / K171008J
- Conditions
- Pressure Ulcers, Nursing Cares, Decubitus Ulcer, Pressure Injury
- 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
- 36 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 5 Mar 2018 (actual)
- Primary completion
- 13 Sep 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 5 Mar 2018 (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 (PU) represent a major health issue because of their high incidence and of their important consequences. There is an important risk of pressure ulcer acquisition for ICU patient with acute organ failure.
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 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 study will assess feasibility, efficacy and tolerance of a repositioning schedule applied to ICU adult patients. The repositioning schedule will be daily adapted to pressure ulcer risk of the patient assessed with Braden scale.
If results of this pilot study show improvement by the application of the repositioning schedule, they will argue the realization of a multicenter randomized clinical trial. This larger study will assess the expected decrease of pressure ulcers incidence due to the schedule and of its benefit-risk ratio.
This is a one-center prospective pilot study which includes two one-month consequential periods:
- During the first period, care will be delivered according usual practice. It is an observational phase.
- The second period will begin with medical and nurse staff training. Then, care will be delivered according the repositioning schedule. It's an interventional phase.
The procedure will be prescribed every day on patient's prescription by the doctor in charge (that will be filed with medical record).
- During the two periods: Every morning, inclusion and non-inclusion criteria will be sought for every patient intubated for at least 24 hours. This evaluation will be made by a nurse during daily medical staff meeting.
Eligible patients will be informed. Their consent will be collected and they will be included in the study. Patient characteristics (age, gender, BMI, simplified acute physiology score SAPS II, Sequential Organ Failure Assessment (SOFA) Score, length of mechanical ventilation, length of stay and mortality in ICU) will be taken from the PMSI. Those data are usually daily collected.
During the second period: data about Braden scale, positioning schedule, different positions applied, possible adverse events during positioning and presence of pressure ulcer will be collected by caregivers and nurses caring the patient.
Those data will be collected on the "daily positioning sheet" made available in patient's room. Skin condition will be evaluated on the 28th day, or when leaving ICU wall, or at death if it occurs before. Clinical research technician will control concordance between repositioning data and position applied by caregivers and nurses and those recommended by the schedule.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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 occurrence of pressure ulcer in adult ICU in comparison with the routine patient management (without positioning schedule adapted on PU risk) at the 28th day, or when leaving ICU wall, or at death if it occurs before.
| Arm | Type | Receives |
|---|---|---|
| Positioning schedule | Experimental | Procedure: Positioning scheduleApplying repositioning schedule daily adapted to pressure ulcer risk assessed with Braden scale. Then, the nurse will applied oil for PU prevention and repositioning which frequency will be defined by the Braden score. The positions will be the semi-fowler 30-30, the half-sitting position with a 45° angle position and patient lying on their back with the head up with a 30° angle for ventilator associated pneumonia prevention. Repositioning schedule will be applied according to the daily medical prescription. When physician allows to sit the patient on a chair, this have to be done by raising feet on a stool. Therefore, patients will stay in that chair as long as defined by positioning schedule. When patient is returned to bed, same positions as described above will be used alternately. In the time of positioning care, oil usually used for PU prevention will be applied on the skin of the areas of high risk of PU (heels, sacrum, elbows, trochanter, knees) and bone projections. |
| Common repositioning practice | No intervention | –pressure ulcer prevention cares are provided according to usual practice. 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 (3 listed)
- Expected duration of invasive ventilation: more than 24 hours at inclusion;
- No pressure ulcer at inclusion (using of a tool developed from the European Pressure Ulcer Advisory Panel);;
- Information of the patient, or if it is not possible information of his relatives, or emergency procedure if contacting relatives is not possible. Consent document will then be signed by the patient as soon as he is able to do.
Key exclusion criteria (7 listed)
- Under than 18 years;
- Pregnant woman;
- protected adult as defined by the law;
- Person without any health insurance;
- 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;
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 programApplying repositioning schedule daily adapted to pressure ulcer risk assessed with Braden scale. Then, the nurse will applied oil for PU prevention and repositioning which frequency will be defined by the Braden score. The positions will be the semi-fowler 30-30, the half-sitting position with a 45° angle position and patient lying on their back with the head up with a 30° angle for ventilator associated pneumonia prevention. Repositioning schedule will be applied according to the daily medical prescription. When physician allows to sit the patient on a chair, this have to be done by raising feet on a stool. Therefore, patients will stay in that chair as long as defined by positioning schedule. When patient is returned to bed, same positions as described above will be used alternately. In the time of positioning care, oil usually used for PU prevention will be applied on the skin of the areas of high risk of PU (heels, sacrum, elbows, trochanter, knees) and bone projections. | Procedure or surgery | Positioning schedule |
Primary outcome
positioning schedule efficacy
Time frame: 28 days
To assess efficacy of a positioning schedule whose frequency of positioning is adapted every day to pressure ulcer risk assessed by Braden scale in adult ICU, compared to usual PU prevention management (without schedule daily adapted to PU risk) at the 28th day, or when leaving ICU wall, or at death if it occurs before.
4 secondary outcomes
Caregivers commitment to the standardized positioning schedule in adult ICU (1)
Time frame: 28 days
Caregivers commitment to the standardized positioning schedule in adult ICU (2)
Time frame: 28 days
nursing workload
Time frame: 28 days
clinical safety of the positioning schedule
Time frame: 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 14 Nov 2018.
- Individual participant dataSharing planned: No. It is planned to share data to argue the realization of a multicenter trial on this theme. This data can be shared by different way including e-mail transfer.
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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.
MEHAY Daisy, RN principal investigator
Service de réanimation médico chirurgicale, Hôpital Tenon (AP-HP), Paris
FARTOUKH Muriel, MD study director
Service de réanimation médico chirurgicale, Hôpital Tenon (AP-HP), 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 Ulcers and Nursing Cares, 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 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 14 Nov 2018. 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?
positioning schedule efficacy (time frame: 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 14 Nov 2018.