MedTrace Logo

Cerebral Oximetric Monitoring of the Posterior Circulation

NCT00751712 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 13

Last updated 2016-03-29

No results posted yet for this study

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 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.

Conditions

  • Congenital Heart Disease

Interventions

DEVICE

Cerebral oximeter sensor

The INVOS Cerebral Oximeter utilizes two electrodes to monitor cerebral oxygenation. The recommended placement of these electrodes is on the forehead to monitor the frontal cortex. In this study, one electrode will be placed in the normal position on the forehead, and the other will be placed at the base of the skull. The stickers will be placed on the patient at the beginning of surgery and removed at the end. The maximum amount of time that they will be on the patient's skin is approximately six hours. Application of the stickers and the data they provide will not alter the provider's treatment plan. This procedure will be used for all enrolled patients, whether they are enrolled in Part I or Part II.

Sponsors & Collaborators

  • Children's Hospitals and Clinics of Minnesota

    lead OTHER

Principal Investigators

  • David M Overman, MD · Children's Heart Clinic

Eligibility

Min Age
1 Day
Max Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2008-04-30
Completion
2008-04-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00751712 on ClinicalTrials.gov