Continuous Monitoring of Physiological Parameters for Early Detection of Complications in Postoperative Vascular Surgical Patients - An Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Physiologic abnormal vital signs - Cumulative duration
研究概览
简要总结
Vascular postsurgical patients have a high risk of morbidity and mortality. On top of that, patients undergoing vascular surgery usually have a high burden of comorbidities.
After a short stay in the post-operative ward, patients are usually transferred to a standard surgical ward.
Monitoring of physiological parameters by intermittent manual recordings 8-12 hours apart, is today's standard of care in hospitals. However, no effect on length of hospital stay, morbidity or mortality has been proven. This may be due to the up to 12 hours of unobserved time that can occur, where physiological deviations can progress resulting in clinical adverse outcomes such as myocardial infarction or stroke.
Vital sign micro events are occurrences when patient physiological parameters deviates significantly from what can be understood as normal physiology. Since adverse outcomes in patients rarely happens without deviating physiological parameters, it is to be investigated if micro events can be used to predict clinical adverse outcomes to patients. We acknowledge that during the observation period, the number of false alarms should be kept to a minimum to avoid the risk of 'alarm fatigue'
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients admitted to Copenhagen University Hospital
- •Patients with Peripheral Arteriel Disease(PAD)
- •Patients undergoing open infraligamentary revascularization
- •Emergency or subacute surgery
- •Admission the day before surgery, and expected length of stay more than 2 days.
排除标准
- •Patient expected not to cooperate
- •Patients with dementia or not able to give informed consent
- •Patient allergic to plaster, plastic or silicone
- •Patients with pacemaker or implantable cardioverter-defibrillator (ICD) unit
- •Patients in isolation
- •Active therapy withdrawn
- •Patients previously included in the other study branches
- •Patients with >20 mmHg in difference in systolic blood pressure between the two arms.
- •Expected discharge within less than 24 hours from possible inclusion
结局指标
主要结局
Physiologic abnormal vital signs - Cumulative duration
时间窗: From inclusion until 4 days or discharge
Cumulative duration of physiologic vital signs within certain thresholds outside normalcy
次要结局
- Physiologic abnormal vital signs - Episodes of sustained duration(From inclusion until 4 days or discharge)
研究者
Eske Kvanner Aasvang
Dr. Med.
Rigshospitalet, Denmark