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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02060825
Recruitment Status : Terminated (Difficulty in downloading and saving data from the oximetry machine.)
First Posted : February 12, 2014
Last Update Posted : February 1, 2017
Information provided by (Responsible Party):
Aymen N Naguib, Nationwide Children's Hospital

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).

Condition or disease Intervention/treatment
Congenital Heart Disease Device: Regional saturation monitor

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Study Type : Observational
Actual Enrollment : 16 participants
Observational Model: Case-Only
Time Perspective: Prospective
Study Start Date : November 2012
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Group/Cohort Intervention/treatment
Regional saturation monitor
Patients undergoing surgical repair of hypoplastic left heart syndrome.
Device: Regional saturation monitor
Other Name: Casmed

Primary Outcome Measures :
  1. Intestinal perfusion [ Time Frame: Immediate post-op period (24 - 96 hours) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing surgical repair of hypoplastic left heart syndrome.

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02060825

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United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Aymen N Naguib

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Responsible Party: Aymen N Naguib, Director of Pediatric Cardiothoracic Anesthesia, Nationwide Children's Hospital Identifier: NCT02060825     History of Changes
Other Study ID Numbers: IRB12-00687
First Posted: February 12, 2014    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases