Cerebral Oximetric Monitoring of the Posterior Circulation

Completed

Conditions studied: Congenital Heart Disease

In brief

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 brain with blood during this operation, selective cerebral perfusion is sometimes used. This technique allows for adequate blood flow to the brain, and is monitored using special sticker sensors. The sensors are applied to the patient's forehead, and a corresponding monitor indicates oxygen levels in the front part of the brain. The goal of this study is to find out if these same stickers can be applied to the base of the skull to measure cerebral oxygenation at the back of the brain, and to determine if the back of the brain is adequately oxygenated during selective cerebral perfusion in patients undergoing complex aortic arch reconstruction.

Key facts

Study ID

NCT00751712

Run by

Children's Hospitals and Clinics of Minnesota

People needed

13

Starts

2006-05-01

Expected to finish

2008-04-01

Last updated by the study team

2016-03-29

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Children's Hospitals and Clinics of Minnesota — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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