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

NCT ID: NCT02630550

Last Updated: 2015-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-30

Brief Summary

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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

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Conditions

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Aortic Aneurysm Peripheral Arterial Disease

Keywords

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Aortic Aneurysm Repair

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.

Cheetah NICOM

Intervention Type DEVICE

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

Transesophageal echocardiography (TEE)

Intervention Type DEVICE

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

Femoral Endarterectomy

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.

Cheetah NICOM

Intervention Type DEVICE

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

Transesophageal echocardiography (TEE)

Intervention Type DEVICE

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

Interventions

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Cheetah NICOM

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

Intervention Type DEVICE

Transesophageal echocardiography (TEE)

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maisonneuve-Rosemont Hospital

OTHER

Sponsor Role lead

Responsible Party

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Louis-Philippe Fortier

Department Head - Anesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Louis-Philippe Fortier, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Maisonneuve-Rosemont Hospital

Locations

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Maisonneuve-Rosemont Hospital

Montreal, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Eric Peters

Role: CONTACT

Phone: 514-252-3400

Nadia Godin, RN

Role: CONTACT

Phone: 514-252-3400

Facility Contacts

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Nadia Godin, RN

Role: primary

Other Identifiers

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15042

Identifier Type: -

Identifier Source: org_study_id