Integrated Proactive Wireless Monitoring for Clinical Deterioration: A Stepped Wedge Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 13,160
- 主要终点
- Composite endpoint of 30-day in-hospital mortality, cardiac arrest, requirement of vasopressor or intubation
研究概览
简要总结
The study evaluates whether implementing a wireless monitoring system for patients admitted to hospital wards reduces mortality and cardiopulmonary failure.
详细描述
The trial is designed as a stepped-wedge cluster RCT. Hospital wards (which constitute clusters in this design) will be randomized to have wireless monitoring, 7 wards at a time, with each 7 wards constituting a sequence. The study consists of 5 periods of two-month sequences followed by a one-month transition time with a phased introduction of the intervention. In the first period, all wards will have no wireless monitoring. After a baseline period of 2 (+1 washout) months, the intervention (monitoring system) will be implemented in a randomly selected new sequence every 3-month period until the intervention is implemented in all sequences.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
The randomization list will be maintained with a research coordinator who is not involved in this trial, and the ward allocation will remain concealed from the research and clinical teams throughout the study and will be revealed for a given sequence only 1 month before the implementation of the intervention to allow training.
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ward level Inpatient wards, defined as wards used to manage adult inpatients.
- •Patient level
- •Aged 14 years or older
- •Checked in as inpatient status to one of the study wards
排除标准
- •Cardiology, pediatric, obstetric wards
- •ICUs and emergency departments
- •Operating rooms
- •Outpatient clinics
- •Daycare wards, endoscopy, outpatient procedure areas, hemodialysis units
- •Patient level No commitment for full life support at the time of arrival to the study ward (designated as Do-Not-Resuscitate status)
结局指标
主要结局
Composite endpoint of 30-day in-hospital mortality, cardiac arrest, requirement of vasopressor or intubation
时间窗: 30 days
After hospital admission within 30 days
次要结局
- Cardiac arrest(30 days)
- Requirement of vasopressors(within 30 days of hospital admission)
- Requirement of intubation(30 days)
- Hospital length of stay(90 days)
- Transfer to ICU(30 days)
- ICU- free days(30 days)
- CCRT activation(30 days)
研究者
Dr Yaseen Arabi
Chairman intensive care unit
King Saud Bin Abdulaziz University for Health Sciences