Assessment of an Alternative to Physical Wrist Restraints in Adult Intubated Patients in the Intensive Care Unit: The HEALiX™ Intubated Patient (IP) Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Unplanned removal of devices
研究概览
简要总结
The current standard of care for limiting the movement of mechanically ventilated critical care patients is the use of physical wrist restraints, which are both ineffective in preventing removal of invasive and adjunct respiratory support devices and have a multitude of negative physical and psychological consequences for the patient. The objective of the proposed research is to test an innovative device designed to allow more freedom of movement of mechanically ventilated patients without bending of the arms, thereby preventing removal of adjunct mechanical ventilation devices and invasive monitoring equipment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •speak English
- •legally authorized representative must speak English
- •admitted by one of the services presiding over the selected intensive care units
- •mechanically ventilated receiving analgesic-sedating medications
- •have soft wrist restraints applied as part of their care plan documented in the medical record to reduce the risk of unplanned removal of medical devices
排除标准
- •pregnant women
- •prisoners
- •patients who are in a medically induced coma or in a comatose state (Glasgow Coma Scale <8) for any reason
结局指标
主要结局
Unplanned removal of devices
时间窗: up to 2 weeks
Frequency of unplanned removal of lines and self-extubation
次要结局
- Ease of device use(up to 2 weeks)
- Alternate device use(up to 2 weeks)
- Ease of application(up to 1 week)
- Acceptability of device(up to 1 week)
- Availability of device(up to 2 weeks)
- Education around device(up to 12 weeks)
