跳至主要内容
临床试验/NCT04759066
NCT04759066撤回不适用

Assessment of an Alternative to Physical Wrist Restraints in Adult Intubated Patients in the Intensive Care Unit: The HEALiX™ Intubated Patient (IP) Pilot Study

Lancaster General Hospital2 个研究点 分布在 1 个国家开始时间: 2021年10月1日最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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