NCT02630550

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 2, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 15, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Last Updated

December 15, 2015

Status Verified

December 1, 2015

Enrollment Period

11 months

First QC Date

December 2, 2015

Last Update Submit

December 10, 2015

Conditions

Aortic AneurysmPeripheral Arterial Disease

Keywords

Cardiac outputIntraoperative MonitoringEchocardiography, TransesophagealVascular cross-clampingEndarterectomyMonitoring, Physiologic/instrumentationCardiography, Impedance

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Stroke Volume (SV) with a vascular cross-clamp

    Per vascular surgery procedure when a cross-clamp is installed

  • Stroke Volume (SV) trending ability

    Per vascular surgery procedure

Study Arms (2)

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.

Device: Cheetah NICOMDevice: Transesophageal echocardiography (TEE)

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.

Device: Cheetah NICOMDevice: Transesophageal echocardiography (TEE)

Interventions

Cheetah NICOMDEVICE

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

Aortic Aneurysm RepairFemoral Endarterectomy
Transesophageal echocardiography (TEE)DEVICE

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

Aortic Aneurysm RepairFemoral Endarterectomy

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing either an open aortic aneurysm repair surgery or a femoral endarterectomy under general anesthesia.

You may qualify if:

  • Patient undergoing an elective open aortic aneurysm repair surgery or a femoral endarterectomy under general anesthesia.
  • ASA 1-3

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maisonneuve-Rosemont Hospital

Montreal, Quebec, H1T 2M4, Canada

RECRUITING

MeSH Terms

Conditions

Aortic AneurysmPeripheral Arterial Disease

Interventions

Echocardiography, Transesophageal

Condition Hierarchy (Ancestors)

AneurysmVascular DiseasesCardiovascular DiseasesAortic DiseasesAtherosclerosisArteriosclerosisArterial Occlusive DiseasesPeripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

EchocardiographyCardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Study Officials

  • Louis-Philippe Fortier, MD, MSc

    Maisonneuve-Rosemont Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric Peters

CONTACT

514-252-3400

Nadia Godin, RN

CONTACT

514-252-3400

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department Head - Anesthesia

Study Record Dates

First Submitted

December 2, 2015

First Posted

December 15, 2015

Study Start

November 1, 2015

Primary Completion

October 1, 2016

Last Updated

December 15, 2015

Record last verified: 2015-12

Locations

CA(1)