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临床试验/NCT03375476
NCT03375476已完成不适用

Evaluation of a Model for Post-anesthesia Troponin Increase and Heart Injury Estimation

ASST Fatebenefratelli Sacco1 个研究点 分布在 1 个国家目标入组 117 人开始时间: 2018年4月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
117
试验地点
1
主要终点
Prediction of Postoperative Myocardial Ischemia

研究概览

简要总结

This study evaluates the preoperative cardiovascular risk, the intraoperative hemodynamic characteristics and the surgical photo-plethysmographic index of patients undergoing general anesthesia for non-cardiac vascular surgery to develop a multiple variable model assessing the risk for postoperative myocardial ischemic events.

详细描述

Perioperative cardiac troponin leak is common and is strongly associated with mortality even in absence of classic myocardial infarction signs. In the VISION study 11.6% of patients undergoing non-cardiac surgery were troponin positive and 1.9% (95%CI 1.7-2.1%) of those patients died within 30 days of surgery. In selected populations of patients undergoing vascular surgery, a postoperative cTn leak, without clinical features of myocardial ischemia, is associated with an increased risk of 30-day mortality (odds ratio 5.03, 95% CI 2.88-8.79). Myocardial oxygen supply-demand imbalance and plaque rupture/thrombosis are the main mechanism involved in the pathogenesis of postoperative myocardial ischemic events. Frequently cardiac troponin leaks occur in absence of classical signs and symptoms of myocardial infarction. More than 80% of patients with postoperative cardiac troponin leak are clinically asymptomatic for myocardial ischemia, and ischemic ECG changes are often absent.

The identification of patients who will experience a postoperative myocardial ischemia will continue to be a challenge for anaesthesiologists.The current tool used for risk stratification using the AHA/ACC algorithm is Lee's Revised Cardiac Risk Index. Unfortunately, this tool can only reliably exclude low-risk patients and cannot identify patients which are likely to have perioperative cardiovascular complications.

The surgical plethysmographic index (SPI, GE Healthcare, Finland) during general anaesthesia has been correlated with the stressors of surgery (e.g. intubation, incision, ...), and with stress hormone production. It has been demonstrated that SPI and other pulse photo-plethysmographic indices reflect sympathetic-mediated vasoconstriction, thus monitoring the SPI during general anesthesia could lead to a reduced sympathetic response to surgical stimuli. Unfortunately there is not a desirable level of SPI, and it is unknown if difference in SPI values during the surgery might affect the postoperative outcome.

Intraoperative hemodynamic parameters and SPI will be recorded in conjunction with preoperative cardiovascular risk scores and will be used to develop a multiple variable model for postoperative risk of myocardial ischemic events.

In this study Electrocardiogram, invasive arterial pressure, photoplethysmography,and electroencephalographic entropy will be collected continuously from 10 min before induction of general anesthesia until 20 min after awakening from anesthesia. Gupta's score and Revised Cardiac Risk Index will be recorded the day before surgery.

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 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients scheduled for elective non-cardiac vascular surgery under general anesthesia

排除标准

  • Raynaud's phemomenon
  • permanent atrial fibrillation or non sinus rhythm on ECG or ectopic beats >5% of normal sinus beats
  • implanted with pacemaker
  • any circulation problem in forefingers
  • scheduled for postoperative ICU admission
  • a new therapy with beta-blockers started <7 days before the surgery

结局指标

主要结局

Prediction of Postoperative Myocardial Ischemia

时间窗: 72 hours after the surgery

Cox's proportional model of preoperative cardiovascular risk scores and physiologic intraoperative variables for prediction of the occurrence of Postoperative Myocardial Ischemia

次要结局

  • prediction of postoperative myocardial ischemic events or stroke(30 days)
  • mortality(30 and 90 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Riccardo Colombo

Principal Investigator

ASST Fatebenefratelli Sacco

研究点 (1)

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