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

Maisonneuve-Rosemont Hospital

Status: Unknown

Conditions: Aortic Aneurysm; Peripheral Arterial Disease

Treatments: Device: Transesophageal echocardiography (TEE); Device: Cheetah NICOM

Study type: Observational

Funder types: Other

Identifiers

NCT02630550

15042

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

20 participants in 2 patient groups

Aortic Aneurysm Repair

Description:

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.

Treatment:

Device: Transesophageal echocardiography (TEE)

Device: Cheetah NICOM

Femoral Endarterectomy

Description:

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.

Treatment:

Device: Transesophageal echocardiography (TEE)

Device: Cheetah NICOM