Status:

COMPLETED

Cerebral Oximetric Monitoring of the Posterior Circulation

Lead Sponsor:

Children's Hospitals and Clinics of Minnesota

Conditions:

Congenital Heart Disease

Eligibility:

All Genders

1-12 years

Brief Summary

One known risk of pediatric heart surgery is the possibility for brain damage. This problem results from a lack of oxygen rich blood flow to the brain during surgery. In order to provide the patient's...

Detailed Description

One known risk of pediatric heart surgery is the possibility for brain damage. In may cases this problem results from a lack of oxygen rick blood flow to the brain during surgery. Recently, a techniqu...

Eligibility Criteria

Inclusion

  • Part I: Neonates or infants undergoing congenital heart surgery other than complex aortic arch reconstruction where surgical time is expected to be \>= 1 hour in duration.
  • Part 2: Neonates or infants with complex aortic arch reconstruction where surgical time is expected to be \>=1 hour in duration.

Exclusion

  • Neonates or infants with hydrocephalus
  • Perinatal brain injury
  • CNS (Central Nervous System) pathology, hemangiomas
  • Cranial abnormalities
  • Aortic or brachial anatomy that disallows performance of a shunt
  • Skin conditions such as eczema or cradle cap.

Key Trial Info

Start Date :

May 1 2006

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

April 1 2008

Estimated Enrollment :

13 Patients enrolled

Trial Details

Trial ID

NCT00751712

Start Date

May 1 2006

End Date

April 1 2008

Last Update

March 29 2016

Active Locations (1)

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Children's Hospitals and Clinics of Minnesota

Minneapolis, Minnesota, United States, 55404