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

Validation of Measurement of Cardiac Output With LiDCO Rapid and TEE (Trans Esophageal Echocardiography) by Comparing With Intermittent Thermodilution Technique in Cardiac Surgical Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02511457
Enrollment
110
Registered
2015-07-30
Start date
2012-10-31
Completion date
2015-08-31
Last updated
2016-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Cardiac Output

Brief summary

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

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.

Interventions

None listed

Sponsors

University of Iowa
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
30 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* Elective cardiac procedures other than those specified in the

Design outcomes

Primary

MeasureTime frame
The primary objective of the study is measured cardiac output by LiDCO Rapid is as equivalent ( within 30%) as measured by pulmonary artery catheter using intermittent thermodilution method among patients undergoing elective cardiac surgery.During intraoperative period.

Secondary

MeasureTime frame
The secondary objective of the study is measured cardiac output by TEE using VTI at LVOT is as equivalent ( within 30%) as measured by pulmonary artery catheter using intermittent thermodilution method among patients undergoing elective cardiac surgery.During intraoperative period

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026