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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02630550

Enrollment

Registered

2015-12-15

Start date

2015-11-30

Completion date

Unknown

Last updated

2015-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Aneurysm, Peripheral Arterial Disease

Keywords

Cardiac output, Intraoperative Monitoring, Echocardiography, Transesophageal, Vascular cross-clamping, Endarterectomy, Monitoring, Physiologic/instrumentation, Cardiography, Impedance

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.

Interventions

DEVICECheetah NICOM

The Cheetah NICOM will be installed on all patients to evaluate the validity of its measurements.

DEVICETransesophageal echocardiography (TEE)

TEE will serve as gold standard measurements for the evaluation of the Cheetah NICOM.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Canada

Contacts

Primary ContactEric Peters

514-252-3400

Backup ContactNadia Godin, RN