跳至主要内容
临床试验/NCT02375412
NCT02375412已完成不适用

Preoperative Evaluation of Autonomic Nervous System by Heart Rate Variability as a Predictor of Postoperative Outcome in the Patient Undergoing Major Elective Abdominal Surgery

University Hospital Ostrava1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2015年2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
65
试验地点
1
主要终点
Pre-defined postoperative complications for up to 28 days after surgery

研究概览

简要总结

The purpose of the study is to confirm the hypothesis that a dysfunction of the autonomic nervous system could complicate the postoperative course in the patient undergoing surgery. Measurement of heart rate variability (HRV) is a non-invasive method for evaluation of the autonomic nervous system.

详细描述

The autonomic nervous system (ANS) plays an important role in the maintenance of systemic homeostasis. The homeostasis is modified continually by internal and external stimuli to which the autonomic nervous system modulates the response of organism by tight control on essential functions such as circulation, respiration, hormonal secretion and thermoregulation. Dysfunction of the autonomic nervous system could complicate the perioperative course in the patient undergoing surgery; therefore it should be considered as another risk factor during preoperative evaluation. Nowadays the evaluation of the autonomic nervous system function like a tool for prediction postoperative outcome is not considered in daily anaesthesiology practice. Measurement of heart rate variability (HRV) is a method for evaluation the autonomic nervous system function. It is a non-invasive method that provides information about the autonomic regulation of organism and thus it identifies patients with the autonomic nervous system dysfunction.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
21 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 21 years of age and above
  • anticipated duration of surgery more than 120 minutes
  • estimated blood loss exceeding more than 15% of blood volume
  • American Society of Anesthesiology (ASA) classification 2 or 3

排除标准

  • pregnant or lactating women
  • age below 21 years of age
  • emergency surgery
  • American Society of Anesthesiology (ASA) classification 1
  • sepsis and septic shock
  • severe cardiac arrhythmias

结局指标

主要结局

Pre-defined postoperative complications for up to 28 days after surgery

时间窗: 24 months

The followed postoperative complications include infectious, respiratory, cardiovascular, abdominal, renal complications, massive postoperative bleeding and preoperative death.

次要结局

  • The length of hospitalization(24 months)

研究者

发起方
University Hospital Ostrava
申办方类型
Other
责任方
Sponsor

研究点 (1)

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