CardioQ vs Thermodilution Measurements of Cardiac Output

NCT01744795 — Not applicable, Completed, 25 participants, Hasse Moller-Sorensen

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Comparison of CardioQ and Pulmonary Artery Thermodilution Derived Cardiac Output Measurements

Registry	NCT01744795
Status	Completed
Phase	Not applicable
Study type	Interventional; na, single group, masking: double, diagnostic
Enrollment	25 (Estimated)
Sponsor	Hasse Moller-Sorensen (Other)
Conditions	Comparison of CardioQ and Thermodilution Derived Cardiac Output Measurements
Interventions	induced changes in hemodynamics (Other)
Dates	start 2012-12-01, primary completion 2013-06-01, completion 2013-06-01, first posted 2012-12-07, last updated 2013-06-19
Locations	2 sites in Denmark

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
induced changes in hemodynamics	Experimental	Other: 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.

induced changes in hemodynamics (Other): 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 TEE and thermodilution technique.

+Outcome measures

Primary outcomes

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.

+Eligibility

Sex: All, ages: 18 Years to 90 Years

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:

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+Locations (2)

Facility	City	Country	Status
Rigshospitalet, University of Copenhagen	Copenhagen, Capital Region	Denmark
Department of Cardiothoracic anesthesiology; Rigshospitalet	Copenhagen	Denmark