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
  Purpose

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."


Condition Intervention
Cardiac Output
Device: HCE101 Cardiopulmonary Support Monitor

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Ultrasound Dilution Measurement of Cardiac Output Before and After Adult Cardiopulmonary Bypass

Resource links provided by NLM:


Further study details as provided by Transonic Systems Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 25
Study Start Date: July 2007
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Device: HCE101 Cardiopulmonary Support Monitor
Measurement of cardiac output before and after cardiopulmonary bypass in adult patients.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01103895

Locations
United States, New York
Arnot Ogden Medical Center
Elmira, New York, United States, 14905
Sponsors and Collaborators
Transonic Systems Inc.
Investigators
Principal Investigator: Nikolai Krivitski, PhD, DSc Transonic Systems Inc.
Principal Investigator: Edward P Nast, MD Arnot Ogden Medical Center
  More Information

No publications provided

Responsible Party: Transonic Systems Inc.
ClinicalTrials.gov Identifier: NCT01103895     History of Changes
Other Study ID Numbers: TSI-C-HCE101-4A-H, 2R44HL082022-02
Study First Received: April 13, 2010
Last Updated: June 4, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Transonic Systems Inc.:
cardiac output
cardiopulmonary bypass
ultrasound dilution

ClinicalTrials.gov processed this record on September 16, 2014