NCT04640415已完成不适用
Continuous Wireless Monitoring of Vital Signs and Automated Alerts of Patient Deterioration vs. Routine Monitoring of High-risk Patients After Major Surgery. A Randomized Controlled Trial.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 4
- 主要终点
- Cumulative duration
研究概览
简要总结
The primary aim of the current study is to assess the effect of continuous wireless vital sign monitoring with generation of real-time alerts, compared to blinded monitoring without alerts on the cumulative duration of any severely deviating vital signs in patients admitted to general hospital wards after major surgery.
We hypothesize that continuous vital signs monitoring, and real-time alerts will reduce the cumulative duration of severely deviating vital signs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admission for acute or elective major abdominal (laparotomy/laparoscopy), major orthopedic, major urologic, or arterial vascular surgery.
- •Estimated duration of surgery ≥2 hours and at least two expected overnight stays.
- •Randomization and commencement of continuous wireless monitoring possible within 24 hours postoperatively
排除标准
- •Patient expected not to cooperate with study procedures.
- •Allergy to plaster or silicone.
- •Impaired cognitive function (in uncertain cases assessed by a Mini Mental State Examination] score < 24)
- •Patients admitted for palliative care only (i.e. no active treatment).
- •Planned admission to unit using continuous vital sign monitoring (i.e. an intermediary care/telemetry unit).
- •Patients previously enrolled in the medical WARD RCT.
- •Patients with a pacemaker or Implantable Cardioverter Defibrillator (ICD) device.
- •Inability to give informed consent.
结局指标
主要结局
Cumulative duration
时间窗: During monitoring, for a maximum of up to 5 postoperative days or until discharge.
Cumulative duration of one or more deviations in vital signs. List of vital signs, and normal limits detailed in protocol.
次要结局
- Frequency of sustained deviation alerts(During monitoring, for a maximum of up to 5 postoperative days or until discharge.)
- Any adverse event(7 days and 30 days after start of monitoring)
- Any serious adverse event(7 days and 30 days after start of monitoring)
研究者
Jesper Mølgaard
MD, Ph.d student
Rigshospitalet, Denmark
研究点 (4)
Loading locations...
相似试验
已完成
不适用
Automated Alerts of Patient Deterioration vs. Routine Monitoring of High-risk Patients Admitted to Medical WardsAlert Fatigue, Health PersonnelDeterioration, ClinicalNCT04661748University Hospital Bispebjerg and Frederiksberg300
已完成
不适用
Continuous and Wireless Vital Sign Monitoring in Patients at Home After Acute Medical AdmissionVital Sign MonitoringClinical DeteriorationDisease ProgressionDisease AttributesNCT05536206Bispebjerg Hospital30
已完成
不适用
Advanced Multimodal Wireless Vital Signs Monitoring for Patients With Asthma and AnaphylaxisAsthma in ChildrenAllergyNCT04360213Northwestern University5
招募中
不适用
Continuous Vital Sign Monitoring in NewbornsNewborn ComplicationNCT04154618Northwell Health1,000
已完成
不适用
Advanced Wireless, Wearable Sensors for Continuous Hemodynamic MonitoringCongestive Heart FailureNCT04362553Northwestern University42