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Clinical Trials/NCT02630550
NCT02630550
Unknown
N/A

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

Maisonneuve-Rosemont Hospital1 site in 1 country20 target enrollmentNovember 2015

Overview

Phase
N/A
Intervention
Not specified
Conditions
Aortic Aneurysm
Sponsor
Maisonneuve-Rosemont Hospital
Enrollment
20
Locations
1
Primary Endpoint
Validity of Stroke Volume (SV) Measurements by the Cheetah NICOM
Last Updated
10 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
November 2015
End Date
October 2016
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Louis-Philippe Fortier

Department Head - Anesthesia

Maisonneuve-Rosemont Hospital

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

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

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (1)

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