CardioQ vs Thermodilution Measurements of Cardiac Output

Comparison of CardioQ and Thermodilution Derived Cardiac Output Measurements Clinical Trial

Official title:

Comparison of CardioQ and Pulmonary Artery Thermodilution Derived Cardiac Output Measurements

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01744795
• Other study ID #: H-3-2012-063
• Status: Completed
• Phase: N/A
• First received: December 4, 2012
• Last updated: June 17, 2013
• Start date: December 2012
• Est. completion date: June 2013

Study information

• Verified date: June 2013
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Scientific-Ethics Committee of the Capital RegionDenmark: Regional data-registry unit; Rigshospitalet
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Comparison of CardioQ and Thermodilution Derived Cardiac Output Measurements

Intervention

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.

Locations

Country	Name	City	State
Denmark	Department of Cardiothoracic anesthesiology; Rigshospitalet	Copenhagen
Denmark	Rigshospitalet, University of Copenhagen	Copenhagen	Capital region

Sponsors (1)

Lead Sponsor	Collaborator
Hasse Moller-Sorensen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Agreement of cardiac output determined with CardioQ, compared with thermodilution	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.	Data are collected in the perioperative period (30min.)	No