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

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.

Study Overview

• Status: Unknown
• Conditions: Peripheral Arterial Disease; Aortic Aneurysm
• Intervention / Treatment: Device: Cheetah NICOM; Device: Transesophageal echocardiography (TEE)

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

• Study Contact: Name: Eric Peters; Phone Number: 514-252-3400
• Study Contact Backup: Name: Nadia Godin, RN; Phone Number: 3193 514-252-3400

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H1T 2M4
      • Recruiting
      • Maisonneuve-Rosemont Hospital
      • Contact: Nadia Godin, RN; Phone Number: 3193 252-3400; Email: ngodin.hmr@ssss.gouv.qc.ca
      • Principal Investigator: Louis-Philippe Fortier, MSc,MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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 NICOM; The Cheetah NICOM will be installed on all patients to evaluate the validity of its measurements.; Device: Transesophageal echocardiography (TEE); 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.	Device: Cheetah NICOM; The Cheetah NICOM will be installed on all patients to evaluate the validity of its measurements.; Device: Transesophageal echocardiography (TEE); TEE will serve as gold standard measurements for the evaluation of the Cheetah NICOM.

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

Collaborators and Investigators

• Sponsor: Maisonneuve-Rosemont Hospital
• Investigators: Principal Investigator: Louis-Philippe Fortier, MD, MSc, Maisonneuve-Rosemont Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (ANTICIPATED): October 1, 2016

Study Registration Dates

• First Submitted: December 2, 2015
• First Submitted That Met QC Criteria: December 10, 2015
• First Posted (ESTIMATE): December 15, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): December 15, 2015
• Last Update Submitted That Met QC Criteria: December 10, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Cardiac output; Endarterectomy; Intraoperative Monitoring; Echocardiography, Transesophageal; Cardiography, Impedance; Vascular cross-clamping; Monitoring, Physiologic/instrumentation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Aortic Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases; Aneurysm; Aortic Aneurysm
• Other Study ID Numbers: 15042