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Clinical Trials/NCT02964663
NCT02964663CompletedNot Applicable

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

Université Libre de Bruxelles1 site in 1 country19 target enrollmentStarted: November 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
19
Locations
1
Primary Endpoint
interchangeability of both devices (esCCO vs VV)

Study Overview

Brief Summary

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.

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

interchangeability of both devices (esCCO vs VV)

Time Frame: 6 months

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sarah Saxena

MD

Université Libre de Bruxelles

Study Sites (1)

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