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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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 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, 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.

Sponsor: University of Iowa

Current Primary Outcome: 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. [ Time Frame: During intraoperative period. ]

Original Primary Outcome: Same as current

Current Secondary Outcome: 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. [ Time Frame: During intraoperative period ]

Original Secondary Outcome: Same as current

Information By: University of Iowa

Dates:
Date Received: July 24, 2015
Date Started: October 2012
Date Completion:
Last Updated: October 24, 2016
Last Verified: October 2016