Comparison of the Ability of the esCCO and the Volume View to Measure Trends in Cardiac Output During Cardiac Surgery

The purpose of this study was to compare CO measured by two easy to use non-invasive monitors, the esCCO (Nihon Kohden, Tokyo, Japan) to the Volume View (Edwards Lifesciences, Irvine, USA) and to assess their trending ability in patients undergoing cardiac surgery.

Study Overview

• Status: Completed
• Conditions: Anesthesia; Cardiac Output, Low
• Intervention / Treatment: Device: esCCO

Detailed Description

Cardiac output (CO) is a major physiological variable that should be monitored closely during cardiac surgery in order to assess and guide therapeutic interventions so as to decrease postoperative morbidity. The purpose of this study was to compare CO measured by two easy to use non-invasive monitors, the esCCO (Nihon Kohden, Tokyo, Japan) to the Volume View (Edwards Lifesciences, Irvine, USA) and to assess their trending ability in patients undergoing cardiac surgery. After Internal review board approval and written informed consent, 19 patients were included in this study. Before cardiopulmonary bypass (CPB), CO was measured simultaneously using both the esCCO and the Volume View device before and after 3 CO-modifying maneuvers [passive leg raise (PLR), end expiratory occlusion test (EEOT) and positive end expiratory pressure (PEEP) at 10 cm H2O. Five CO values for esCCO and three for volume view were averaged and compared during a one minute period of time before and after each maneuver. The precision error and its 95% confidence interval (CI) that corresponds to the least significant change (LSC) were calculated within this period of time. The Bland-Altman analysis was used to compare bias, precision and limits of agreement (LOA) of both devices. Trending ability of CO changes was assessed by a modified 4 quadrant plot analysis, within angular limits of agreement considered as acceptable when the mean angle between both delta CO was less than 30°.

• Study Type: Observational
• Enrollment (Actual): 19

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1070
    • Erasme hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients scheduled for elective cardiac surgery

Description

Inclusion Criteria:

• patients scheduled for elective cardiac surgery

Exclusion Criteria:

• age less than 18 years
• known or potential pregnancy
• arrhythmias
• known significant tricuspid or aortic valve insufficiency
• left or right ventricular dysfunction
• peripheral arteriopathy
• low perfusion index.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
interchangeability of both devices (esCCO vs VV)	CO (L/min) was measured using esCCO and VV before and after 3 CO-modifying maneuvers (passive leg raise, PEEP of 10 cmH20, end expiratory occlusion test. Five CO values for esCCO and three for VV were averaged and compared during one minute period of time before and after each maneuver.	6 months

Collaborators and Investigators

• Sponsor: Université Libre de Bruxelles

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: November 5, 2016
• First Submitted That Met QC Criteria: November 10, 2016
• First Posted (Estimate): November 16, 2016

Study Record Updates

• Last Update Posted (Estimate): November 16, 2016
• Last Update Submitted That Met QC Criteria: November 10, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Cardiac Output, Low
• Other Study ID Numbers: EsCCO vs VV