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临床试验/NCT02658006
NCT02658006已完成不适用

Evaluation of Multimodal Monitoring Technologies in the Peri-operative Care of Cardiac Surgical Patients

Montreal Heart Institute1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2015年11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
120
试验地点
1
主要终点
Right ventricular failure

研究概览

简要总结

The purpose of this prospective observational cohort study is to evaluate multimodal monitoring technologies in the perioperative care of cardiac surgical patients. Right ventricular pressure tracings, near infrared spectroscopy (NIRS) and transthoracic ultrasonography will be studied for their ability to detect and predict complications such as right ventricular failure, renal failure and respiratory failure.

详细描述

The study has 4 main objectives:

  1. To determine if right ventricular pressure tracings correlate with other indices of right ventricular failure and with positive fluid balance, renal failure and increased length of stay in the intensive care unit.
  2. To determine the prevalence of portal vein pulsatility in the perioperative period and its association with right ventricular failure and positive fluid balance.
  3. To determine if Near InfraRed Spectroscopy (NIRS) values correlate with mixed venous oxygen saturation (SvO2) and with poorer post-operative prognosis.
  4. To determine the incidence, risk factors and prognosis of respiratory complications of cardiac surgery using transthoracic ultrasonography.

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

入选标准

  • Cardiac surgery performed at the Montreal Heart Institute
  • 18 years old and older

排除标准

  • Urgent surgery
  • Pre-operative intra-aortic balloon pump, left ventricular assist device or ECMO
  • Heart transplant
  • Cirrhosis

结局指标

主要结局

Right ventricular failure

时间窗: First 24 hours post cardiac surgery

Pulmonary complications

时间窗: 30 days

Composite outcome : pneumonia, prolonged mechanical ventilation (more than 24 hours) or clinically significant atelectasis (requiring \> 2L O2).

Acute Renal failure

时间窗: 30 days

KDIGO : class I and more

次要结局

  • Maximal blood lactate levels(First 24h)
  • Fluid balance(First 24h)

研究者

发起方
Montreal Heart Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Andre Denault

MD PhD FRCPC ABIM-CCM

Montreal Heart Institute

研究点 (1)

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