Pilot Study for Evaluation of the Procedure Impact of Mobilization Adapted to Pressure Ulcer Risk for Patients in Intensive Care.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- positioning schedule efficacy
研究概览
简要总结
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...).
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Positioning schedule (Procedure)
Common repositioning practice
pressure ulcer prevention cares are provided according to usual practice. Frequency and modality of positioning applied to the patients are collected.
结局指标
主要结局
positioning schedule efficacy
时间窗: 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.
次要结局
- Caregivers commitment to the standardized positioning schedule in adult ICU (2)(28 days)
- nursing workload(28 days)
- Caregivers commitment to the standardized positioning schedule in adult ICU (1)(28 days)
- clinical safety of the positioning schedule(28 days)