跳至主要内容
临床试验/NCT02630550
NCT02630550Unknown不适用

Validation of the Cheetah NICOM by Comparison to TEE During Open Vascular Surgery - Pilot Study

Maisonneuve-Rosemont Hospital1 个研究点 分布在 1 个国家目标入组 20 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
入组人数
20
试验地点
1
主要终点
Validity of Stroke Volume (SV) Measurements by the Cheetah NICOM

研究概览

简要总结

The Cheetah NICOM is a non-invasive cardiac output monitor that has been validated in various clinical contexts but not during the occlusion of major arteries, as takes place in vascular surgery. The present study will evaluate the precision and validity of the measures taken by the device during open vascular surgery procedures. The measurements will be compared to the those calculated by transesophageal echocardiography at various key points during the surgeries. The validity of the cardiac output, stroke volume and stroke volume variation measurements will be evaluated, as well as the device's ability to track rapid changes in cardiac output.

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

入选标准

  • Patient undergoing an elective open aortic aneurysm repair surgery or a femoral endarterectomy under general anesthesia.

排除标准

  • Refuses general anesthesia
  • Contraindication to transesophageal echocardiography
  • Allergy to the glue of the Cheetah NICOM probes
  • Severe aortic valve regurgitation
  • Thoracic aorta anatomy anomaly
  • Unipolar pacemaker

结局指标

主要结局

Validity of Stroke Volume (SV) Measurements by the Cheetah NICOM

时间窗: Per vascular surgery procedure

The SV measured by the Cheetah NICOM will be compared to the one measured by transesophageal echocardiography at multiple time points during the surgery.

次要结局

  • Stroke Volume (SV) with a vascular cross-clamp(Per vascular surgery procedure when a cross-clamp is installed)
  • Stroke Volume (SV) trending ability(Per vascular surgery procedure)

研究者

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

Louis-Philippe Fortier

Department Head - Anesthesia

Maisonneuve-Rosemont Hospital

研究点 (1)

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