Cardiac Output Measurement at the Conclusion of Cardiopulmonary Bypass

This study has been terminated.
(Site PI left current position and study was not continued due to lack of a suitable replacement PI.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Transonic Systems Inc.
ClinicalTrials.gov Identifier:
NCT01103908
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 pediatric patients undergoing surgery involving cardiopulmonary bypass (CPB). Cardiac output will be measured after cardiopulmonary bypass using a device that employs ultrasound dilution technology. At times, cardiac output will be measured during a procedure called modified ultrafiltration (MUF). The ultrasound dilution cardiac output measurements will be validated or compared with cardiac output measurements made using other FDA approved techniques and devices.


Condition Intervention
Cardiac Output
Device: HCE101 Cardiopulmonary Support Monitor

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Ultrasound Dilution Cardiac Output at the Conclusion of Cardiopulmonary Bypass in Pediatric Patients

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 in pediatric patients after undergoing surgery involving cardiopulmonary bypass


Enrollment: 3
Study Start Date: April 2010
Study Completion Date: August 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pediatric cardiac output (CO) after CPB
Cardiac output measurements made in pediatric patients after cardiopulmonary bypass.
Device: HCE101 Cardiopulmonary Support Monitor
Measurement of cardiac output using ultrasound dilution technology.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pediatric patients (age < 21 years)
  • Pediatric patients undergoing surgery involving cardiopulmonary bypass

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: NCT01103908

Locations
United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Transonic Systems Inc.
Investigators
Principal Investigator: Nikolai Krivitski, PhD, DSc Transonic Systems Inc.
Principal Investigator: Alistair Phillips, MD Nationwide Children's Hospital
  More Information

No publications provided

Responsible Party: Transonic Systems Inc.
ClinicalTrials.gov Identifier: NCT01103908     History of Changes
Other Study ID Numbers: TSI-G-HCE101-5A-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 October 19, 2014