Congenital Heart DiseaseCerebralOxNCT00751712
Cerebral Oximetric Monitoring of the Posterior Circulation
An observational study of Congenital Heart Disease, run by Children's Hospitals and Clinics of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 12 months
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- Cerebral oximeter sensor
- Type of treatment
- Medical device
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to Apr 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 12 months
- All sexes
- No healthy volunteers
- Child
Study population: Neonates or infants undergoing heart surgery
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, 55404
About this study
Official title: Cerebral Oximetric Monitoring of the Posterior Circulation in Neonates and Infants During Complex Aortic Arch Reconstruction.
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.
Read the 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 the aortic arch, but it is sometimes used. 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.
There are two parts to this study, with part 1 used to assess feasibility:
Part 1: The goal of part one is to find out if these stickers can accurately show whether or not blood is getting to the back of the brain. Patients undergoing heart surgery who are not getting complex aortic arch reconstruction will be enrolled for part 1.
Part 2: If it is found that the stickers do work, part 2 will enroll patients who are undergoing complex aortic arch reconstruction. The goal of part 2 is to find out if the technique known as selective cerebral perfusion is effective at getting blood to the back of the brain during complex aortic arch reconstruction.
The study procedures for part 1 and 2 will be the same, with one sticker being placed in the normal position of the forehead, and the other sticker placed at the base of the skull. Application and data collected from the stickers in parts 1 and 2 will not affect surgical treatments.
- Conditions
- Congenital Heart Disease
- Being tested
- Cerebral oximeter sensor
- Keywords
- Aortic Arch
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerebral oximeter sensorDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Cerebral oximeter sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observational
Measured: Duration of Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2008 (estimated)
- Study startMay 2006
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospitals and Clinics of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David M Overman, MD, Study chair, Children's Heart Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00751712
- Sponsor's protocol ID
- 0511086
- Acronym
- CerebralOx
- Status last verified
- Mar 2016
- First submitted
- 11 Sep 2008
- Last updated
- 29 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Oximetric Monitoring of the Posterior Circulation in Neonates and Infants During Complex Aortic Arch Reconstruction.
- ClinicalTrials.gov ID
- NCT00751712
- Acronym / sponsor ID
- CerebralOx / 0511086
- Conditions
- Congenital Heart Disease
- Keywords
- Aortic Arch
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Children's Hospitals and Clinics of MinnesotaUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 12 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 the aortic arch, but it is sometimes used. 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.
There are two parts to this study, with part 1 used to assess feasibility:
Part 1: The goal of part one is to find out if these stickers can accurately show whether or not blood is getting to the back of the brain. Patients undergoing heart surgery who are not getting complex aortic arch reconstruction will be enrolled for part 1.
Part 2: If it is found that the stickers do work, part 2 will enroll patients who are undergoing complex aortic arch reconstruction. The goal of part 2 is to find out if the technique known as selective cerebral perfusion is effective at getting blood to the back of the brain during complex aortic arch reconstruction.
The study procedures for part 1 and 2 will be the same, with one sticker being placed in the normal position of the forehead, and the other sticker placed at the base of the skull. Application and data collected from the stickers in parts 1 and 2 will not affect surgical treatments.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Back of skull cerebral oximeter sensor | – | Device: Cerebral oximeter sensorAll patients enrolled will receive non-invasive oxygen perfusion monitoring on the back of the skull during their standard of care congenital heart surgery |
Who may qualify
- Ages
- 1 day to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Neonates or infants undergoing heart surgery
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cerebral oximeter sensorThe 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. | Device | Back of skull cerebral oximeter sensor |
Primary outcome
Observational
Time frame: Duration of Surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David M Overman, MD study chair
Children's Heart Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease, run by Children's Hospitals and Clinics of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observational (time frame: Duration of Surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2016.