Estimation of Cardiac Output in Neonatal ICU Using an Ultrasound Dilution Technique (CH)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Transonic Systems Inc..
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Transonic Systems Inc.
ClinicalTrials.gov Identifier:
NCT01610622
First received: May 30, 2012
Last updated: June 4, 2012
Last verified: June 2012
  Purpose

Presently there is no apparatus, clinically available, for routine determination of cardiac output (CO) in children. The goal of this research is to develop new technology that will help determine CO in neonates.


Condition Intervention
Neonatal Intensive Care
Device: COstatus cardiac output measurement with isotonic saline

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Estimation of Cardiac Output in Neonatal ICU Using an Ultrasound Dilution Technique

Resource links provided by NLM:


Further study details as provided by Transonic Systems Inc.:

Estimated Enrollment: 25
Study Start Date: March 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: COstatus cardiac output measurement with isotonic saline

    Isotonic saline, which is the indicator, is injected to obtain COstatus cardiac output measurements.

    No other interventions are made for the purpose of the study.

  Eligibility

Ages Eligible for Study:   up to 1 Month
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients from Neonatal Intensive Care Unit

Criteria

Inclusion Criteria:

  • All neonatal patients cared for in our ICU with umbilical venous and arterial catheters simultaneously in place for their care, will be eligible.

Exclusion Criteria:

  • Patients would be excluded if the family/guardian denied permission or if the attending physician felt the patient was not stable.
  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: NCT01610622

Contacts
Contact: Bonnie L Marr, MD georges_mom@yahoo.com

Locations
United States, New York
Crouse Hospital Recruiting
Syracuse, New York, United States, 13210
Contact: Bonnie Marr, MD       georges_mom@yahoo.com   
Sponsors and Collaborators
Transonic Systems Inc.
Investigators
Principal Investigator: Bonnie Marr, MD Crouse Hospital
  More Information

No publications provided

Responsible Party: Transonic Systems Inc.
ClinicalTrials.gov Identifier: NCT01610622     History of Changes
Other Study ID Numbers: TSI-C-COSTATUS-4A-H, R44HL061994
Study First Received: May 30, 2012
Last Updated: June 4, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Transonic Systems Inc.:
Cardiac Output
Blood volumes
Neonates

ClinicalTrials.gov processed this record on September 18, 2014