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临床试验/NCT00481234
NCT00481234已完成不适用

Heart Rate Variability for Prediction of Incidence of Cardiac Ischemia and Cardiovascular Events After General Anesthesia in High Risk Patients

University Hospital Schleswig-Holstein1 个研究点 分布在 1 个国家目标入组 2,002 人开始时间: 2002年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
2,002
试验地点
1

研究概览

简要总结

Patients with underlying cardiovascular disease are at high risk of perioperative cardiovascular events and death. Hemodynamic variables are controlled by the autonomic nervous system reflected by Heart Rate Variability. To investigate whether differences of HRV parameters predict perioperative cardiovascular events.

详细描述

Hypotension and bradycardia following induction of anesthesia may result in insufficient organ perfusion. Patients with underlying cardiovascular disease are at high risk of perioperative cardiovascular events and death. Hemodynamic variables are controlled by the autonomic nervous system reflected by Heart Rate Variability (HRV). Several authors demonstrated depressed long-term HRV in patients with underlying cardiovascular disease. Depressed 24 hours HRV proved to be highly predictive for cardiovascular morbidity and mortality Recently, short-term analysis was demonstrated to be a reliable tool to predict hypotension after spinal anesthesia. No data are available, however, with respect to preoperative HRV values and incidence of postoperative cardiovascular events. To investigate the prognostic value of HRV in patients with underlying cardiovascular disease. Hypothesise i) differences in pre-operative HRV are present in patients with underlying cardiovascular disease, ii) depressed preoperative HRV indicates high risk of post-operative cardiac ischemia, iii) depressed preoperative HRV is associated with longer postoperative hospital stay and adverse cardiac events after hospital discharge.

First, patients are assigned to one of two groups depending on the presence or absence of postoperative cardiac ischemia; second, a predictive model will be built to confirm our findings prospectively in another group of patients.

Patients: 100 patients (ASA physical status class II - IV) scheduled for general anesthesia. Inclusion criteria:evidence of high perioperative cardiovascular risk based on the Revised Cardiac Risk Index (RCRI >3).Exclusion criteria: lack of sinus rhythm, emergency cases, postoperative admission to an intensive care unit and age under 18 years. Time and frequency domain parameters of HRV will be recorded at the day of surgery before induction of anesthesia. Cardiovascular events and outcome will be analyzed.

研究设计

研究类型
Observational
观察模型
Defined Population
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with cardiovascular risk factors defined as Revised Cardiac Risk Index score <= 3 scheduled for general anesthesia

排除标准

  • Lack of sinus rhythm, emergency cases, age < 18 years

研究者

发起方
University Hospital Schleswig-Holstein
申办方类型
Other

研究点 (1)

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