Pressure Ulcer Clinical Trial
— PROMESREAOfficial title:
Evaluation of the Impact of the Repositioning Schedule Adapted to the Risk of Pressure Ulcer of Patients in Intensive Care Unit
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…).
Status | Recruiting |
Enrollment | 1232 |
Est. completion date | May 2024 |
Est. primary completion date | May 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Service de Réanimation Médico-chirurgicale. Hôpital Tenon, AP-HP | Paris | Ile De France |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
Up to 28 days | |
Secondary | 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. |
Up to 28 days | |
Secondary | Impact of repositioning schedule on the length of hospitalization in intensive care unit | Length of intensive care unit stay | Up to 28 days | |
Secondary | 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. | Up to 28 days | |
Secondary | 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. | Up to 28 days | |
Secondary | 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. | Up to 28 days | |
Secondary | 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. | Up to 28 days | |
Secondary | 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; | Up to 28 days | |
Secondary | 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. | Up to 28 days |
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