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NCT02630550 Clinical Trial

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

Peripheral Arterial Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02630550
Other study ID # 15042
Secondary ID
Status Recruiting
Phase N/A
First received December 2, 2015
Last updated December 10, 2015
Start date November 2015

Study information
Verified date December 2015
Source Maisonneuve-Rosemont Hospital
Contact Eric Peters
Phone 514-252-3400
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date
Est. primary completion date October 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

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

- ASA 1-3

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Device:
• Cheetah NICOM
The Cheetah NICOM will be installed on all patients to evaluate the validity of its measurements.
• Transesophageal echocardiography (TEE)
TEE will serve as gold standard measurements for the evaluation of the Cheetah NICOM.

Locations
Country Name City State
Canada Maisonneuve-Rosemont Hospital Montréal Quebec

Sponsors (1)
Lead Sponsor Collaborator
Maisonneuve-Rosemont Hospital

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Validity of Stroke Volume (SV) Measurements by the Cheetah NICOM The SV measured by the Cheetah NICOM will be compared to the one measured by transesophageal echocardiography at multiple time points during the surgery. Per vascular surgery procedure No
Secondary Stroke Volume (SV) with a vascular cross-clamp The SV measured by the Cheetah NICOM will be compared to the one measured by transesophageal echocardiography at multiple points once a vascular cross-clamp is installed. Per vascular surgery procedure when a cross-clamp is installed No
Secondary Stroke Volume (SV) trending ability Between each pair of consecutive data points, the change of SV measurements given by the Cheetah NICOM will be compared to those given by transesophageal echocardiography. Per vascular surgery procedure No
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