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

Neonatal Intensive Care Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01610622
• Other study ID #: TSI-C-COSTATUS-4A-H
• Secondary ID: R44HL061994
• Status: Completed
• Phase: N/A
• First received: May 30, 2012
• Last updated: May 25, 2016
• Start date: March 2012
• Est. completion date: May 2013

Study information

• Verified date: May 2016
• Source: Transonic Systems Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 1 Month

Eligibility

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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Neonatal Intensive Care

Intervention

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.

Locations

Country	Name	City	State
United States	Crouse Hospital	Syracuse	New York

Sponsors (2)

Lead Sponsor	Collaborator
Transonic Systems Inc.	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States,