NCT02300441已完成不适用
HI-VISION - Hypotension Myocardial Ischemia-Vascular Events In Noncardiac Surgery Patients: a Cohort Evaluation: Pilot Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 133
- 试验地点
- 1
- 主要终点
- Hypotension and Hypoxemia (baseline patterns and frequencies)
研究概览
简要总结
A prospective cohort pilot study of non-cardiac patients to determine the feasibility of recruiting 150 patients to undergo postoperative continuous hemodynamic monitoring for up to 3 days.
详细描述
Patient will start wearing the Philips' hemodynamic and ECG monitor in the Post Anaesthesia Care Unit (PACU). This device will continuously measure heart rate, pulse oxymetry, and ST-segments. The device will measure blood pressure every hour from 7 am to 10 pm and every 2 hours from 10 pm to 7 am.
Patients will have postoperative Troponin I monitoring and telephone follow-up at 30 days postop.
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •We will enroll patients aged 45 years or older undergoing noncardiac surgery who fulfilled 2 or more of the following risk factors:
- •History of coronary artery disease
- •History of stroke or transient ischemic attack (TIA)
- •History of hypertension
- •History of diabetes
- •History of peripheral vascular disease
- •History of congestive heart failure
- •Preoperative creatinine > 175 umol/L
- •A planned admission for ≥48 hours
- •Patients receiving a general or regional anesthetic
排除标准
- •Patients unable to provide informed consent.
- •Patients who undergo procedure performed under infiltrative or topical anesthesia.
- •Patients previously enrolled in the HI-VISION Study.
- •Patients who refuse 30-day follow-up.
结局指标
主要结局
Hypotension and Hypoxemia (baseline patterns and frequencies)
时间窗: 10 months
To identify baseline patterns and frequencies of hypotension and hypoxemia.
次要结局
- Myocardial Ischemia (association between myocardial ischemia detected by the algorithm implemented by MX40 with Troponin I)(10 months)
- Myocardial Ischemia (delay in detecting clinically important hypotension, bradycardia, and hypoxia based on routine monitoring in clinical practice versus remote, automated, non-invasive hemodynamic monitoring.)(10 months)
- Myocardial Ischemia (delay in detecting myocardial ischemia based on MX40 monitoring versus Troponin I monitoring)(10 months)
- Myocardial Ischemia (number of patients with missed clinically important hypotension, bradycardia, and hypoxia based on routine monitoring in clinical practice versus remote, automated, non-invasive hemodynamic monitoring)(10 months)
研究者
研究点 (1)
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