Surveillance of High-risk Early Postsurgical Patients for Real-time Detection of Complications Using Continuing Wireless Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 747
- 试验地点
- 2
- 主要终点
- Disability-free survival
研究概览
简要总结
The aim of this study is to test the hypothesis that continuous wireless monitoring on the postsurgical ward will improve patient outcome, measured as disability-free survival at three months after surgery. Further, the investigators hypothesize that this tight control regimen decreases length of hospital stay and treatment costs in patients with complications.
详细描述
Every year, approximately 1,500,000 surgical procedures are performed in The Netherlands alone. After major surgery, the complication rate is conservatively estimated at 25%, with a rate of 15% for major complications. In these patients, the most important problems are a failure to timely detect developing complications and a failure to adequately rescue those patients. Currently, measurement of vital signs and standardized assessment of patient wellbeing are routinely performed intermittently for every 8-12 hours, which may lead to a failure to detect of patients with complications.
The aim of this study is to test the hypothesis that continuous wireless monitoring on the postsurgical ward will improve patient outcome, measured as disability-free survival at three months after surgery. Further, the investigators hypothesize that this tight control regimen decreases length of hospital stay and treatment costs in patients with complications.
The investigators will carry out this study as an interventional, randomized (per surgical ward), prospective, clinical trial; participating wards will be included using a stepped-wedge design.
Primary outcome is disability-free survival at three months after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients undergoing acute or elective major or intermediate surgery
- •American Society of Anesthesiology (ASA) score of I to IV
排除标准
- •Inability to give written and informed consent
- •Refusal to participate
研究组 & 干预措施
Control
Routine monitoring
Continuous wireless monitoring
Continuous wireless monitoring
干预措施: Continuous wireless monitoring (Device)
结局指标
主要结局
Disability-free survival
时间窗: 3 months
Disability-free survival as measured by the World Health Organization Disability Assessment Schedule (WHODAS) 2.0 questionnaire
次要结局
- 90 day mortality(90 days)
- In-hospital mortality(within 30 days)
- Disability-free survival(1 month)
- Quality of life as measured by EuroQoL questionnaire(3 months)
- Comprehensive Complication Index score (CCI)(within 30 days or until hospital discharge, whatever comes first)
- Patient Health Status(3 months)
- Length of hospital stay(within 30 days or until hospital discharge, whatever comes first)
- 30 day mortality(30 days)
- ICU admission(within 30 days or until hospital discharge, whatever comes first)
- Total number of complications(within 30 days or until hospital discharge, whatever comes first)
- Number of patients with one or more complications (also from the surgical discharge letter)(within 30 days or until hospital discharge, whatever comes first)
- Quality of life as measured by EuroQoL questionnaire(1 month)
- Patient Health Status(1 month)
研究者
B Preckel
Professor of Anesthesiology
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)