Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT02630550
NCT02630550UnknownNot Applicable

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

Maisonneuve-Rosemont Hospital1 site in 1 country20 target enrollmentStarted: November 2015Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
20
Locations
1
Primary Endpoint
Validity of Stroke Volume (SV) Measurements by the Cheetah NICOM
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Louis-Philippe Fortier

Department Head - Anesthesia

Maisonneuve-Rosemont Hospital

Study Sites (1)

Loading locations...

Similar Trials

Terminated
Not Applicable
Comparison Between NICOM-Cheetah and Flotrac-Vigileo for Cardiac Output Monitoring.Cardiac Output, Low
NCT03394768Changi General Hospital26
Completed
Not Applicable
Non-Invasive Cardiac Output Monitor (NICOM) for Goal-directed Fluid Resuscitation for Inpatients With Hypotension and/or Septic ShockSepsisSeptic ShockHypotension
NCT05630716University of Minnesota251
Terminated
Not Applicable
Validation of Nicom Device to Measure Stoke Volume VariationAnesthesia
NCT02485457Hopital Foch2
Completed
Not Applicable
Evaluation of NICOM (Bioreactance) for the Non-invasive Determination of Cardiac OutputCardiac Disease
NCT02331329Universitätsmedizin Mannheim41
Withdrawn
Not Applicable
Cardiac Output Monitoring in Burn PatientsBurns
NCT02404597Emory University
Validation of the Cheetah NICOM by... | Clinical Trial