Cerebral Oximetric Monitoring of the Posterior Circulation (CerebralOx)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Children's Hospitals and Clinics of Minnesota
ClinicalTrials.gov Identifier:
NCT00751712
First received: September 11, 2008
Last updated: June 8, 2012
Last verified: June 2012
  Purpose

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 technique has been developed that allows for adequate blood flow to the brain during surgery, thus decreasing the chances that brain injury will occur as a result of heart surgery. This technique, called selective cerebral perfusion, is not the technique of choice for surgeons operating to repair a part of the main blood vessel in the body known as the aortic arch. The aorta is the main artery that comes out of the heart and carries oxygen rick blood to the body. This large vessel is connected to the heart on one end and then extends upward and forms an arch. At the top of the arch, three vessels branch off and provide the upper part of the body, including the brain, with blood. In a patient with a deformity in the aortic arch, it is necessary to operate to ensure that the flow of blood to the body is adequate and uninterrupted. In order to provide the baby's brain with blood during this operation, the technique mentioned earlier called selective cerebral perfusion is used. In order to understand how selective cerebral perfusion works, it is important to know that the patient will be placed on cardiopulmonary bypass during surgery. During cardiopulmonary bypass, a machine is used to pump blood to the body. This allows the surgeon to work on the heart and surrounding arteries while still providing blood flow of he brain and body. In the past, when surgery involved correction of abnormalities of the aortic arch, cardiopulmonary bypass would have to be stopped and the arch drained of blood, meaning there would be periods of time where the baby's brain would not receive any blood flow.


Condition Intervention
Congenital Heart Disease
Device: Sensor
Device: Testing of Two Sensors

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Cerebral Oximetric Monitoring of the Posterior Circulation in Neonates and Infants During Complex Aortic Arch Reconstruction.

Resource links provided by NLM:


Further study details as provided by Children's Hospitals and Clinics of Minnesota:

Primary Outcome Measures:
  • Observational [ Time Frame: During Surgery ] [ Designated as safety issue: Yes ]

Enrollment: 14
Study Start Date: May 2006
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
Study Control
Device: Sensor
Control
Active Comparator: 2 Device: Testing of Two Sensors
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. Because the electrode stickers need to make direct contact with the skin, a small amount of hair at the base of the skull will need to be shaved. . In this study, 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.

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 technique has been developed that allows for adequate blood flow to the brain during surgery, thus decreasing the chances that brain injury will occur as a result of heart surgery. This technique, called selective cerebral perfusion, is not the technique of choice for surgeons operating to repair a part of the main blood vessel in the body known as the aortic arch. The aorta is the main artery that comes out of the heart and carries oxygen rick blood to the body. This large vessel is connected to the heart on one end and then extends upward and forms an arch. At the top of the arch, three vessels branch off and provide the upper part of the body, including the brain, with blood. In a patient with a deformity in the aortic arch, it is necessary to operate to ensure that the flow of blood to the body is adequate and uninterrupted. In order to provide the baby's brain with blood during this operation, the technique mentioned earlier called selective cerebral perfusion is used. In order to understand how selective cerebral perfusion works, it is important to know that the patient will be placed on cardiopulmonary bypass during surgery. During cardiopulmonary bypass, a machine is used to pump blood to the body. This allows the surgeon to work on the heart and surrounding arteries while still providing blood flow of he brain and body. In the past, when surgery involved correction of abnormalities of the aortic arch, cardiopulmonary bypass would have to be stopped and the arch drained of blood, meaning there would be periods of time where the baby's brain would not receive any blood flow. With selective cerebral perfusion, a small Gore-Tex shunt is attached to one of the blood vessels that branch off of the aortic arch. Blood from the cardiopulmonary bypass machine is them pumped into the shunt where it enters the artery that branches off of the aorta and eventually travels up the neck and into the brain. Other studies have shown that pumping blood into this vessel allows the front portion of the brain to receive blood while the aortic arch abnormality is being corrected. These studies have shown this by using two stickers with special sensors on them that are connected to a monitor. These stickers, when placed on the baby's forehead, show on the monitor whether or not the front part of the brain is receiving blood. The goal of this study is to first find out if these stickers can accurately show whether or not blood is getting to the back of the brain and second, if it is found that the stickers do work, to find out if the technique known as selective cerebral perfusion is effective at getting blood to the back of the brain. In this study, one sticker will be placed in the normal position of the forehead, and the other sticker will be placed at the base of the skull. Because the stickers need to make direct contact with the skin, a small amount of hair at the base of the skull will need to be shaved. With these types of sensors, shaving the area of contact is standard procedure. In this study, 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. As with any adhesive, there is a small risk of a skin rash. This risk will be watched for and treated promptly if it should occur.

  Eligibility

Ages Eligible for Study:   up to 12 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Neonates or infants who will undergo complex aortic arch reconstruction.

Exclusion Criteria:

  • Neonates or infants with hydrocephalus
  • Perinatal brain injury
  • CNS pathology, hemiangiomas
  • Cranial abnormalities
  • Aortic or brachial anatomy that disallows performance of a shunt
  • Skin conditions such as eczema or cradle cap.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00751712

Locations
United States, Minnesota
Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, United States, 55404
Sponsors and Collaborators
Children's Hospitals and Clinics of Minnesota
Investigators
Study Chair: David M Overman, MD Children's Heart Clinic
  More Information

No publications provided

Responsible Party: Children's Hospitals and Clinics of Minnesota
ClinicalTrials.gov Identifier: NCT00751712     History of Changes
Other Study ID Numbers: 0511086
Study First Received: September 11, 2008
Last Updated: June 8, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on April 22, 2014