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Comparison of Cardiac Output With LiDCO Rapid and TEE Against Thermodilution Technique in Cardiac Surgery

NCT ID: NCT02511457

Last Updated: 2016-10-25

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

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2015-08-31

Brief Summary

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Measurement of the cardiac output is one of the important hemodynamic monitoring tools in cardiac surgery. It helps determine the type of medications needed to maintain optimal hemodynamic status in the entire perioperative period. Thermodilution method using pulmonary artery catheter is considered has the gold standard for the measurement of cardiac output. Investigators would like to compare the most popular minimally-invasive devices used to measure cardiac output using arterial waveform: LiDCO Rapid and TEE with the thermodilution method at various phases of the cardiac surgery.

Detailed Description

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Measurement of the cardiac output is one of the important hemodynamic monitoring tools in cardiac surgery. It helps determine the type of medications needed to maintain optimal hemodynamic status in the entire perioperative period. Thermodilution method using pulmonary artery catheter is considered has the gold standard for the measurement of cardiac output, however over the past 10 to 15 years it has been questioned about its safety and efficacy. There has been a surge in recent years of less invasive devices capable of measuring cardiac output by various means, including bioimpedance, transpulmonary thermodilution, transthoracic and transesophageal echocardiography, and arterial waveform analysis.

There is a variety of devices currently available for cardiac output measurement by arterial-waveform analysis. These devices have been compared to each other, and to the pulmonary artery catheter as the gold standard. However, the companies manufacturing these devices have made software upgrades that they believe improves their performance. No studies have been performed comparing the uncalibrated arterial waveform based cardiac output measurement device,LiDCORapid since the software upgrades. In addition to baseline cardiac output measurements, Investigators intend to study the effect of volume loading (by trendelenburg position), sympathetic stimulus (incision), a vasodilated state (15 minutes after separation from CPB) and chest closure on cardiac output measured by the three different techniques.

In addition to cardiac output the investigators would like to measure stroke volume ,Systemic Vascular Resistance, stroke volume variation with LiDCO . The main purpose is to validate the accuracy of measurements by these two minimally-invasive methods in comparison with thermodilution method in various hemodynamic states.

Conditions

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Low Cardiac Output

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Exclusion Criteria

* All emergency cardiac procedures, prisoners and pregnant women, patients who are scheduled for ventricular assist devices and those with severe aortic, mitral and tricuspid insufficiency will be excluded.
Minimum Eligible Age

30 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Iowa

OTHER

Sponsor Role lead

Responsible Party

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Sudhakar Subramani

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sudhakar Subramani, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

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University of Iowa

Iowa City, Iowa, United States

Site Status

Countries

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United States

References

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Hadian M, Kim HK, Severyn DA, Pinsky MR. Cross-comparison of cardiac output trending accuracy of LiDCO, PiCCO, FloTrac and pulmonary artery catheters. Crit Care. 2010;14(6):R212. doi: 10.1186/cc9335. Epub 2010 Nov 23.

Reference Type RESULT
PMID: 21092290 (View on PubMed)

Cecconi M, Dawson D, Casaretti R, Grounds RM, Rhodes A. A prospective study of the accuracy and precision of continuous cardiac output monitoring devices as compared to intermittent thermodilution. Minerva Anestesiol. 2010 Dec;76(12):1010-7. Epub 2010 Jul 16.

Reference Type RESULT
PMID: 20634793 (View on PubMed)

Other Identifiers

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201205760

Identifier Type: -

Identifier Source: org_study_id