Cerebral Oximetric Monitoring of the Posterior Circulation

NCT00751712 | Completed

• 1 other identifier: 0511086
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

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 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

Keywords

Aortic Arch

Outcome Measures

Primary Outcomes (1)

• Observational

  Duration of Surgery

Study Arms (1)

Back of skull cerebral oximeter sensor

All patients enrolled will receive non-invasive oxygen perfusion monitoring on the back of the skull during their standard of care congenital heart surgery

Device: Cerebral oximeter sensor

Interventions

Cerebral oximeter sensor DEVICE

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.

Back of skull cerebral oximeter sensor

Eligibility Criteria

• Age: 1 Day - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Neonates or infants undergoing heart surgery

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.

Sponsors & Collaborators

• Children's Hospitals and Clinics of Minnesota: lead

Study Sites (1)

Children's Hospitals and Clinics of Minnesota

Minneapolis, Minnesota, 55404, United States

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• David M Overman, MD

  Children's Heart Clinic

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2008
• First Posted: September 12, 2008
• Study Start: May 1, 2006
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: March 29, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)