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CardioQ vs Thermodilution Measurements of Cardiac Output

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01744795
First Posted: December 7, 2012
Last Update Posted: June 19, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hasse Moller-Sorensen, Rigshospitalet, Denmark
  Purpose
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.

Condition Intervention
Comparison of CardioQ and Thermodilution Derived Cardiac Output Measurements Other: induced changes in hemodynamics

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Official Title: Comparison of CardioQ and Pulmonary Artery Thermodilution Derived Cardiac Output Measurements

Further study details as provided by Hasse Moller-Sorensen, Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Agreement of cardiac output determined with CardioQ, compared with thermodilution [ Time Frame: 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.


Estimated Enrollment: 25
Study Start Date: December 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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 TEE and thermodilution technique.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01744795


Locations
Denmark
Rigshospitalet, University of Copenhagen
Copenhagen, Capital region, Denmark, 2100
Department of Cardiothoracic anesthesiology; Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Hasse Moller-Sorensen
  More Information

Responsible Party: Hasse Moller-Sorensen, MD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01744795     History of Changes
Other Study ID Numbers: H-3-2012-063
First Submitted: December 4, 2012
First Posted: December 7, 2012
Last Update Posted: June 19, 2013
Last Verified: June 2013

Keywords provided by Hasse Moller-Sorensen, Rigshospitalet, Denmark:
cardiac output
thermodilution
esophageal doppler
trending ability