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

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.

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

Conditions
-----------------
Aortic Aneurysm, Peripheral Arterial Disease

Intervention / Treatment
-----------------
* Device: Cheetah NICOM
* Device: Transesophageal echocardiography (TEE)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Aortic Aneurysm Repair<br>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. | Device: Cheetah NICOM<br>* The Cheetah NICOM will be installed on all patients to evaluate the validity of its measurements.<br>Device: Transesophageal echocardiography (TEE)<br>* TEE will serve as gold standard measurements for the evaluation of the Cheetah NICOM.<br>|
| Femoral Endarterectomy<br>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. | Device: Cheetah NICOM<br>* The Cheetah NICOM will be installed on all patients to evaluate the validity of its measurements.<br>Device: Transesophageal echocardiography (TEE)<br>* TEE will serve as gold standard measurements for the evaluation of the Cheetah NICOM.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiac output, Intraoperative Monitoring, Echocardiography, Transesophageal, Vascular cross-clamping, Endarterectomy, Monitoring, Physiologic/instrumentation, Cardiography, Impedance