Estimation of Cardiac Output in Neonatal ICU Using an Ultrasound Dilution Technique (CH)
This study is currently recruiting participants.
Verified June 2012 by Transonic Systems Inc.
Sponsor:
Transonic Systems Inc.
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
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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 |
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
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 May 16, 2013