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Clinical Trials/NCT02060825
NCT02060825
Terminated
Not Applicable

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

Aymen N Naguib1 site in 1 country16 target enrollmentNovember 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Congenital Heart Disease
Sponsor
Aymen N Naguib
Enrollment
16
Locations
1
Primary Endpoint
Intestinal perfusion
Status
Terminated
Last Updated
9 years ago

Overview

Brief 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).

Registry
clinicaltrials.gov
Start Date
November 2012
End Date
September 2016
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Aymen N Naguib
Responsible Party
Sponsor Investigator
Principal Investigator

Aymen N Naguib

Director of Pediatric Cardiothoracic Anesthesia

Nationwide Children's Hospital

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Intestinal perfusion

Time Frame: Immediate post-op period (24 - 96 hours)

Study Sites (1)

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