CTRI/2018/02/011713进行中(未招募)3 期
Pilot study on using a purpose built device (PreSense) to improve turn-protocol compliance
试验速览
- 阶段
- 3 期
- 状态
- 进行中(未招募)
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- To measure the current rate of compliance with prescribed turning protocols by using the system
研究概览
简要总结
This study is an open arm trial assessing the safety and efficacy of PreSense designed for assisting caregivers in improving patient turn protocol compliance. It will be conducted in multiple centers in India. The primary outcome is to measure the current rate of compliance with prescribed turning protocols by using PreSense and to compare it with the compliance rate prior to the introduction of PreSense.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •All adults admitted to Intensive Care Unit (ICU) who are considered at risk of acquiring pressure ulcers can be enrolled in the study.
排除标准
- •Patients who cannot have the wearable device attached to their chest.
- •Patients who currently have implantable cardiovascular- defibrillator or pacemaker.
结局指标
主要结局
To measure the current rate of compliance with prescribed turning protocols by using the system
时间窗: On completion of pilot study
proposed and to compare it with the compliance rate prior to introduction of the system proposed.
时间窗: On completion of pilot study
次要结局
未报告次要终点
研究者
研究点 (2)
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