Recruiting

Observational Study

Sponsor:

Maisonneuve-Rosemont Hospital

Code:

NCT02630550

Conditions

Aortic Aneurysm

Peripheral Arterial Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Cheetah NICOM

Transesophageal echocardiography (TEE)

Study Details

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.

Conditions

Aortic Aneurysm

Peripheral Arterial Disease

Study ID

NCT02630550

Start date

Nov, 2015

Status verified date

Dec, 2015

Primary completion date

Oct, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Cheetah NICOM

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

Transesophageal echocardiography (TEE)

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

Primary outcome measure

  • Validity of Stroke Volume (SV) Measurements by the Cheetah NICOM [ Time Frame: Per vascular surgery procedure ]

Central Contacts and Locations

Central contacts

Eric Peters

514-252-3400

Nadia Godin, RN

514-252-3400

Locations

Maisonneuve-Rosemont Hospital

Recruiting

Montréal, Quebec, Canada, H1T 2M4

Contacts

Nadia Godin, RN

252-3400ngodin.hmr@ssss.gouv.qc.ca

Principal Investigator:

Louis-Philippe Fortier, MSc,MD

More Information

Sponsor

Maisonneuve-Rosemont Hospital

Last update posted

Dec 15, 2015

Last verified

Dec, 2015

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Maisonneuve-Rosemont Hospital on 2015-12-15.