Characterization of Vital Sign Circadian Fluctuations in Postsurgical Patients With or Without Complications
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 589
- 试验地点
- 1
- 主要终点
- Postoperative complications
研究概览
简要总结
To describe changes in various diurnal patterns in vital values after surgery. These will be analyzed based on whether the patients have complications or no complications.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Admitted for surgery
- •Expected time of surgery was more than 2 hours.
- •Expected post-operative length of stay was more than 2 days.
排除标准
- •Allergy to study materials
- •Patients with a pacemaker
- •Patients that were expected to be unable to cooperate with study procedures (for instance a Mini-Mental State Exam(MMSE < 25)
结局指标
主要结局
Postoperative complications
时间窗: From start of continuous monitoring until 12 hours after monitoring stopped.
Any complication meeting the ICH-GCP serious adverse event(SAE) criteria: An SAE (...) is defined as any untoward medical occurrence that(...) * Results in death * Is life-threatening * Requires inpatient hospitalization or causes prolongation of existing hospitalization * Results in persistent or significant disability/incapacity * Requires intervention to prevent permanent impairment or damage (May have caused a congenital anomaly/birth defect - Not relevant)
次要结局
未报告次要终点
研究者
Jesper Mølgaard
MD, Principal investigator
Rigshospitalet, Denmark