NCT00409370已完成3 期
A Randomized Clinical Trial to Compare The Use Of Safety Net Enclosures With Standard Restraints in Agitated Hospitalized Patients
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Perception of the Nurse
研究概览
简要总结
This study compared standard hospital restraints to a newer safety net restraint system to compare them for acceptability, tolerance, duration of restrain, length of stay in the hospital, and satisfaction of MD, nurse, and relatives of patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •age more than 18
- •hospitalized
- •acute confusion or agitation
排除标准
- •Patients who require acute respiratory or cardiac support such as patients requiring ventilator support or patients in cardiac or septic shock
- •Patients who have a documented history of claustrophobia
- •Patients or family members who refuse to consent for safety net treatment under any circumstances. Failure to obtain consent due to absence of or inability to reach a family member or to give consent to participate in the study
- •Failure to obtain consent due to absence of or inability to reach a family member within reasonable time or to give consent to participate in the study.
- •Acutely ill patients requiring intravenous vasopressors, intubation or ventilatory support
- •Other conditions deemed terminal within 24 hours as determined by the patient's attending physician
- •Patients who stay less than 24 hours in the hospital
- •If patient is already on restrains for more than 48 hours preceding enrollment.
- •If two or more limbs are already on restraint to protect IV lines.
- •Extreme degree of agitation requiring continuous IV sedation or anesthesia. Such patients may pose a danger to staff or themselves if their restraints were to be discontinued in order to put them on study restraints.
- •When the intent of single wrist restraint is only to hold the IV line and patient is not agitated or in delirium.
结局指标
主要结局
Perception of the Nurse
perception of physician
perception of family member
agitated behavior scale
alcohol withdrawal assessment scale
次要结局
- total duration of restraint use
- length of hospital stay
- total sedative medication dose used
研究者
研究点 (2)
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