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NCT02060825 Clinical Trial

The Use of Optical Oximetry in Determining Gastrointestinal Complications After the Hybrid Procedure

Congenital Heart Disease Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02060825
Other study ID # IRB12-00687
Secondary ID
Status Terminated
Phase N/A
First received February 11, 2014
Last updated January 31, 2017
Start date November 2012
Est. completion date September 2016

Study information
Verified date January 2017
Source Nationwide Children's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This project is evaluating the validity of regional saturation monitoring in evaluating changes in the mesenteric perfusion. Regional saturation monitoring is a standard of care in many institutions, including NCH. Advances in the technology and recent approval of the use of CASMED devices for this purpose will allow us to use this technology more effectively. We aim to evaluate if there is a change in the mesenteric blood flow during the pre, intra and post operative period for the hybrid procedure and the balloon atrial septostomy procedure (BAS).

Recruitment information / eligibility
Status Terminated
Enrollment 16
Est. completion date September 2016
Est. primary completion date September 2016
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Diagnosis of single ventricle and undergoing the hybrid procedure pathway.

Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Regional saturation monitor

Locations
Country Name City State
United States Nationwide Children's Hospital Columbus Ohio

Sponsors (1)
Lead Sponsor Collaborator
Aymen N Naguib

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Intestinal perfusion Immediate post-op period (24 - 96 hours)
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