Randomized Control Trial Evaluating Optimal Patient Turning Procedures for Reducing Hospital Acquired Pressure Ulcers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,312
- 试验地点
- 1
- 主要终点
- Count of Participants With Pressure Ulcer According to the National Pressure Ulcer Advisory Panel (NPUAP) Criteria for Pressure Ulcers
研究概览
简要总结
The purpose of this study is to test whether optimal patient turning, strictly every 2 hours with at least 15 minutes of tissue decompression, reduces the occurrence of hospital acquired pressure ulcers.
详细描述
This single site, open label, two arm randomized control trial aims to evaluate whether optimal patient turning, strictly every 2 hours with at least 15 minutes of tissue decompression, reduces the occurrence of hospital acquired pressure ulcers. Optimal turning procedures will be obtained with the use of a patient monitoring system (Leaf Healthcare, Inc.) and compared to standard preventative care practices.
Sensors were placed on all participants as they were admitted to ICU. A nurse's user dashboard was turned on for participants in the Optimal Turning Group, but was not turned on for participants in the Standard Care group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Adults (>18 years of age)
- •Admission to Intensive Care Unit
排除标准
- •Children (<18 years of age)
- •Adhesive allergy
- •Physical limitation for sensor application
研究组 & 干预措施
Treatment - Optimal Turning
All patients will have a sensor applied. Patients within this arm will receive care from nurses who have access to a User Dashboard that provides visual advisories for patient turning, based on data obtained from a wearable patient sensor (Leaf Healthcare, Inc.).
干预措施: Optimal Turning (Other)
Treatment - Optimal Turning
All patients will have a sensor applied. Patients within this arm will receive care from nurses who have access to a User Dashboard that provides visual advisories for patient turning, based on data obtained from a wearable patient sensor (Leaf Healthcare, Inc.).
干预措施: Patient Sensor (Other)
Control - Standard Care
All patients will have a sensor applied. Patients within this arm will receive care from nurses who DO NOT have access to a User Dashboard that provides visual advisories for patient turning. Instead, these patients will receive standard care practices, patient turning initiated by nurses as necessary.
干预措施: Standard Care Practices (Other)
Control - Standard Care
All patients will have a sensor applied. Patients within this arm will receive care from nurses who DO NOT have access to a User Dashboard that provides visual advisories for patient turning. Instead, these patients will receive standard care practices, patient turning initiated by nurses as necessary.
干预措施: Patient Sensor (Other)
结局指标
主要结局
Count of Participants With Pressure Ulcer According to the National Pressure Ulcer Advisory Panel (NPUAP) Criteria for Pressure Ulcers
时间窗: Duration of ICU admission (average 1 week)
NPUAP criteria include 4 stages and 2 unstaged criteria. The count of patients with pressure ulcer according to any of the criteria are reported. * Stage 1: Non-blanchable erythema of intact skin * Stage 2: Partial-thickness skin loss with exposed dermis * Stage 3: Full-thickness skin loss * Stage 4: Full-thickness skin and tissue loss * Unstageable: Obscured full-thickness skin and tissue loss * Suspected deep tissue injury: Persistent non-blanchable deep red, maroon or purple discoloration
次要结局
- Compliance With Patient Turning Procedures(Duration of ICU admission (average 1 week))
研究者
David Pickham
Clinical Assistant Professor
Stanford University