CardioQ vs Thermodilution Measurements of Cardiac Output

Not Applicable

Completed

• Conditions: Comparison of CardioQ and Thermodilution Derived Cardiac Output Measurements
• Interventions: Other: induced changes in hemodynamics

• Registration Number: NCT01744795
• Lead Sponsor: Hasse Moller-Sorensen

Brief Summary

Minimal invasive monitoring systems of central hemodynamics are gaining increasing popularity. The present study investigates the precision of the esophageal doppler (CardioQ) derived cardiac output and its agreement with pulmonary artery catheter thermodilution (PAC TD) for measuring CO during steady state and with induced hemodynamic changes in patients scheduled for elective cardiac surgery.

Detailed Description

Twenty-five patients are planned to be enrolled. After induction of anesthesia, insertion of the PAC and the esophageal-doppler probe, the patient are placed in the following successive positions: a) supine, b) head-down tilt, c) head-up tilt, d) supine, e) supine with phenylephrine administration f) pace heart rate 80 bpm, g) pace heart rate 110 bpm, and CO are measured simultaneously using the CardioQ and PAC TD.

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-04
• Study First Submitted QC: 2012-12-05
• Study First Posted: 2012-12-07
• Status Verified: 2013-06
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Last Update Submitted: 2013-06-17
• Last Update Posted: 2013-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• patients scheduled for elective coronary artery bypass grafting (CABG), who are in stable sinus rhythm, who have a left ventricular ejection fraction > 0.40 measured by transthoracic echocardiography, and who have no significant valve pathology

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
induced changes in hemodynamics	induced changes in hemodynamics	Twenty-five patients are planned enrolled. After induction of anesthesia, insertion of the PAC and the CardioQ probe, the patient are placed in the following successive positions: a) supine, b) head-down tilt, c) head-up tilt, d) supine, e) supine with phenylephrine administration f) pace heart rate 80 bpm, g) pace heart rate 110 bpm. CO are measured simultaneously using the CardioQ and thermodilution technique.

Primary Outcome Measures

Name	Time	Method
Agreement of cardiac output determined with CardioQ, compared with thermodilution	Data are collected in the perioperative period (30min.)	Data are collected for each patient in the perioperative period. Patients are followed in the first 24 hours. Data will after inclusion of the last data be analysed and appropiate statistics aplied.

Trial Locations

Locations (2)

Rigshospitalet, University of Copenhagen; 🇩🇰 Copenhagen, Capital region, Denmark

Department of Cardiothoracic anesthesiology; Rigshospitalet; 🇩🇰 Copenhagen, Denmark