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临床试验/NCT03365726
NCT03365726已完成不适用

Intraoperative Stress Test With Dobutamine and Speckle Tracking to Decrease Postoperative Mortality

McGill University Health Centre/Research Institute of the McGill University Health Centre2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2016年1月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
140
试验地点
2
主要终点
mortality

研究概览

简要总结

Perioperative adverse cardiovascular events are the leading cause of morbidity and mortality after noncardiac surgery. The implications of perioperative cardiac complications on morbidity and mortality, in-hospital and long-term care, and resource utilization are enormous. The continuously increasing proportion of elderly patients presenting for noncardiac surgery raises serious concerns regarding adverse cardiac events in the perioperative period. The responsibility for early diagnosis and prompt treatment of cardiac complications during surgery rests squarely with the anesthesiologist. Reliable intraoperative identification of patients at high risk for postoperative AMI and/or death is currently inadequate, but may confer substantial benefits to patients as preventive measures could be instituted. A reliable and reproducible quantitative measure of regional and global myocardial function could improve preoperative risk stratification and guide anesthetic management when acute changes in myocardial function occur.

In the present study is hypothesized that intraoperative dobutamine stress echocardiography by 2-dimensional speckle tracking echocardiography can identify patients at higher risk of perioperative adverse cardiac events.

详细描述

Due to changes in study execution, analyses focused on prospectively collected physiological data examining myocardial contractile reserve and its association with postoperative myocardial injury

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Any laparotomy
  • Any thoracotomy
  • Any hip surgery
  • Any complex oncologic surgery o Any thoracoscopy

排除标准

  • Females older than 80 year old
  • Patients on chronic systemic corticosteroid therapy
  • Diagnosed pharyngeal or gastro-esophageal pathologies (such as esophageal varices, stricture, diverticula, tumor, esophagitis, Mallory- Weiss tear, or previous surgery for any of these)
  • Signs and symptoms of severe pharyngeal or gastro-esophageal pathologies (including odynophagia, dysphagia)
  • Emergency surgery
  • Age less than 50 year old

研究组 & 干预措施

DST (dobutamine-stress-test)

Experimental

dobutamine stress echocardiography performed to patients undergoing major surgery

干预措施: Dobutamine stress test with trans-esophageal echocardiography (Diagnostic Test)

NDST (no-dobutamine-stress-test)

No Intervention

patients refused the dobutamine stress test and transesophageal echocardiography measured the troponin level in first 24 hours after surgery

结局指标

主要结局

mortality

时间窗: 30 days

mortality

次要结局

  • myocardial infarction(within 30 days after surgery)

研究者

发起方
McGill University Health Centre/Research Institute of the McGill University Health Centre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lina Pietropaoli

MD, PhD

McGill University Health Centre/Research Institute of the McGill University Health Centre

研究点 (2)

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