Pilot Study for Evaluation of the Procedure Impact of Mobilization Adapted to Pressure Ulcer Risk for Patients in Intensive Care. (PROMESReaPilot)

November 13, 2018 updated by: Assistance Publique - Hôpitaux de Paris

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…).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75020
        • Hôpital Tenon, AP-HP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Positioning schedule

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.
Procedure: Positioning schedule

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.

Other Names:
  • Positioning; prevention of pressure ulcers; repositioning program
NO_INTERVENTION: Common repositioning practice
pressure ulcer prevention cares are provided according to usual practice. Frequency and modality of positioning applied to the patients are collected.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
28 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Caregivers commitment to the standardized positioning schedule in adult ICU (1)
Time Frame: 28 days

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.
28 days
Caregivers commitment to the standardized positioning schedule in adult ICU (2)
Time Frame: 28 days

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.
28 days
nursing workload
Time Frame: 28 days
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.
28 days
clinical safety of the positioning schedule
Time Frame: 28 days

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.
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique - Hôpitaux de Paris

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: MEHAY Daisy, RN, Service de réanimation médico chirurgicale, Hôpital Tenon (AP-HP), Paris
  • Study Director: FARTOUKH Muriel, MD, Service de réanimation médico chirurgicale, Hôpital Tenon (AP-HP), Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 5, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 13, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 26, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 5, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 14, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • K171008J
  • 2017-A03038-45 (OTHER: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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