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
• 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. 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

• Aortic Aneurysm
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

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