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

• Conditions: Peripheral Arterial Disease; Aortic Aneurysm
• Interventions: Device: Cheetah NICOM; Device: Transesophageal echocardiography (TEE)

• Registration Number: NCT02630550
• Lead Sponsor: Maisonneuve-Rosemont Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Status Verified: 2015-12
• Study First Submitted: 2015-12-02
• Study First Submitted QC: 2015-12-10
• Last Update Submitted: 2015-12-10
• Study First Posted: 2015-12-15
• Last Update Posted: 2015-12-15
• Primary Completion: 2016-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Aortic Aneurysm Repair	Transesophageal echocardiography (TEE)	The impact of large abdominal retractors and an abdominal aortic cross-clamp on the validity of the Cheetah NICOM's measurements will be evaluated in this group.
Aortic Aneurysm Repair	Cheetah NICOM	The impact of large abdominal retractors and an abdominal aortic cross-clamp on the validity of the Cheetah NICOM's measurements will be evaluated in this group.
Femoral Endarterectomy	Cheetah NICOM	The impact of the clamping of a large peripheral arterial vessel on the validity of the Cheetah NICOM's measurements will be evaluated in this group.
Femoral Endarterectomy	Transesophageal echocardiography (TEE)	The impact of the clamping of a large peripheral arterial vessel on the validity of the Cheetah NICOM's measurements will be evaluated in this group.

Primary Outcome Measures

Name	Time	Method
Validity of Stroke Volume (SV) Measurements by the Cheetah NICOM	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 Outcome Measures

Name	Time	Method
Stroke Volume (SV) with a vascular cross-clamp	Per vascular surgery procedure when a cross-clamp is installed	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.
Stroke Volume (SV) trending ability	Per vascular surgery procedure	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.

Trial Locations

Locations (1)

Maisonneuve-Rosemont Hospital; 🇨🇦 Montréal, Quebec, Canada