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Cardiac Output Measurement at the Conclusion of Cardiopulmonary Bypass

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ClinicalTrials.gov Identifier: NCT01103908
Recruitment Status : Terminated (Site PI left position and lack of a suitable replacement PI.)
First Posted : April 15, 2010
Last Update Posted : May 27, 2016
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Transonic Systems Inc.

Brief Summary:
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 or disease Intervention/treatment
Cardiac Output Device: HCE101 Cardiopulmonary Support Monitor

Study Type : Observational
Actual Enrollment : 3 participants
Time Perspective: Prospective
Official Title: Ultrasound Dilution Cardiac Output at the Conclusion of Cardiopulmonary Bypass in Pediatric Patients
Study Start Date : April 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : August 2011

Group/Cohort Intervention/treatment
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. The ultrasound dilution technology is in the HCE101 Cardiopulmonary Support Monitor.



Primary Outcome Measures :
  1. Cardiac output after cardiopulmonary bypass [ Time Frame: Less than 10 minutes ]
    Cardiac output will be measured in pediatric patients after undergoing surgery involving cardiopulmonary bypass



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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Cardiac output measurements made in pediatric patients after cardiopulmonary bypass.
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)

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): NCT01103908


Locations
United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Transonic Systems Inc.
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Nikolai Krivitski, PhD, DSc Transonic Systems Inc.
Principal Investigator: Alistair Phillips, MD Nationwide Children's Hospital

Responsible Party: Transonic Systems Inc.
ClinicalTrials.gov Identifier: NCT01103908     History of Changes
Other Study ID Numbers: TSI-G-HCE101-5A-H
2R44HL082022-02 ( U.S. NIH Grant/Contract )
First Posted: April 15, 2010    Key Record Dates
Last Update Posted: May 27, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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