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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

19 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-03-31

Brief Summary

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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

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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°.

Conditions

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Cardiac Output, Low Anesthesia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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esCCO

comparison of non-invasive monitoring esCCO vs VV on cardiac output measurements

Intervention Type DEVICE

Other Intervention Names

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VV

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Sarah Saxena

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Erasme Hospital

Brussels, Brussels Capital, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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EsCCO vs VV

Identifier Type: -

Identifier Source: org_study_id