Clinical trial NCT04550182: Evaluation of the Impact of the Repositioning Schedule Adapted to the Risk of Pressure Ulcer of Patients in Intensive Care Unit
Official title: Evaluation of the Impact of the Repositioning Schedule Adapted to the Risk of Pressure Ulcer of Patients in Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
decubitus ulcers
pressure injury
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-09-16
Enrollment: 1232
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

Brief 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).

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

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: The proportion of pressure ulcer at day 28
timeFrame: Up to 28 days
Secondary outcomes:
measure: Tolerance of a repositioning schedule in adult intensive care unit
timeFrame: Up to 28 days
measure: Impact of repositioning schedule on the length of hospitalization in intensive care unit
timeFrame: Up to 28 days
measure: Evaluate the applicability of a repositioning schedule and clinical barriers to patients' repositioning schedule
timeFrame: Up to 28 days
measure: Risk factors for pressure ulcer on critically ill patients
timeFrame: Up to 28 days
measure: Impact of a repositioning schedule on the time spent caring for alternate position procedure prevention in adult intensive care units
timeFrame: Up to 28 days
measure: Impact of a repositioning schedule on the management of bedsores in adult intensive care units
timeFrame: Up to 28 days
measure: Impact of a repositioning schedule on invasive care therapy for pressure ulcers
timeFrame: Up to 28 days
measure: total cost of the procedure and cost per pressure ulcer avoided
timeFrame: Up to 28 days
Other outcomes:
Locations:
city: Paris
country: France
facility: Service de Réanimation Médico-chirurgicale. Hôpital Tenon, AP-HP
state: Ile de France
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Daisy Mehay, Degree Nurse in intensive care
role: PRINCIPAL_INVESTIGATOR
References: