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

NCT ID: NCT02060825

Last Updated: 2017-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-11-30

Study Completion Date

2016-09-30

Brief Summary

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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).

Detailed Description

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Conditions

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Congenital Heart Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Regional saturation monitor

Patients undergoing surgical repair of hypoplastic left heart syndrome.

Regional saturation monitor

Intervention Type DEVICE

Interventions

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Regional saturation monitor

Intervention Type DEVICE

Other Intervention Names

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Casmed

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aymen N Naguib

OTHER

Sponsor Role lead

Responsible Party

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Aymen N Naguib

Director of Pediatric Cardiothoracic Anesthesia

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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IRB12-00687

Identifier Type: -

Identifier Source: org_study_id

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