Measurement of Cardiac Output Before and After Cardiopulmonary Bypass.

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Transonic Systems Inc.
ClinicalTrials.gov Identifier:
NCT01103895
First received: April 13, 2010
Last updated: June 4, 2012
Last verified: June 2012

April 13, 2010
June 4, 2012
July 2007
June 2012   (final data collection date for primary outcome measure)
Cardiac output after cardiopulmonary bypass [ Time Frame: Less than 10 minutes ] [ Designated as safety issue: No ]
Cardiac output will be measured using an ultrasound dilution technique and compared with cardiac output measured using thermodilution after the completion of surgical procedures involving cardiopulmonary bypass.
Same as current
Complete list of historical versions of study NCT01103895 on ClinicalTrials.gov Archive Site
Cardiac output before cardiopulmonary bypass [ Time Frame: Less than 10 minutes ] [ Designated as safety issue: No ]
Cardiac output will be measured using an ultrasound dilution technique and compared to cardiac output measured using thermodilution. This will serve as a baseline measurement of the patient's cardiac output.
Same as current
Not Provided
Not Provided
 
Measurement of Cardiac Output Before and After Cardiopulmonary Bypass.
Ultrasound Dilution Measurement of Cardiac Output Before and After Adult Cardiopulmonary Bypass

Cardiac output, the amount of blood pumped by the heart in one minute, will be measured in adults undergoing surgery involving cardiopulmonary bypass. Cardiac output will be measured before and after cardiopulmonary bypass using a device that employs ultrasound dilution technology. The ultrasound dilution cardiac output measurements will be validated or compared with cardiac output measurements made using thermodilution, which is the current "gold standard."

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Cardiac Output
Device: HCE101 Cardiopulmonary Support Monitor
Measurement of cardiac output before and after cardiopulmonary bypass in adult patients.
Experimental: Adult CO before and after CPB
Measurement of cardiac output before and after cardiopulmonary bypass using an ultrasound dilution technique. Comparison with thermodilution cardiac output before and after cardiopulmonary bypass.
Intervention: Device: HCE101 Cardiopulmonary Support Monitor
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
25
June 2012
June 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients aged > 21 years
  • Patients undergoing surgery involving cardiopulmonary bypass
  • Patients instrumented with a thermodilution catheter

Exclusion Criteria:

  • Patients aged < 21 years
  • Patients undergoing surgery "off pump" (not involving cardiopulmonary bypass)
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01103895
TSI-C-HCE101-4A-H, 2R44HL082022-02
No
Transonic Systems Inc.
Transonic Systems Inc.
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Nikolai Krivitski, PhD, DSc Transonic Systems Inc.
Principal Investigator: Edward P Nast, MD Arnot Ogden Medical Center
Transonic Systems Inc.
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP