- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00754754
Brain Retraction Monitoring Sensor Study
September 14, 2017 updated by: Vanderbilt University
Brain Retraction Monitoring Sensor
The purpose of this study is to utilize a sensor incorporated into a brain retractor blade to monitor electrical activity and pressure applied to the brain during retraction required for the selected skull base operations.
The overall goal of the study is to develop a protocol and guidelines to prevent the development of brain retraction injury during neurosurgical procedures requiring significant retraction.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
During neurosurgical operations for aneurysms, tumors, or other lesions located in the skull base, the surgeon must employ retracting devices in order to displace one or more lobes of the brain enough to gain adequate surgical exposure.
These retractors are adjusted by hand to optimize exposure.
It is often difficult for the surgeon to gauge the amount of pressure actually applied to the brain during such placement of the retractor.
Moreover, it is also possible to position the blade of the retractor inadvertently such that a focal pressure point occurs at the tip of the retractor blade against the brain.
Thus, injury to the brain can occur as a result of brain retraction when either the force applied is excessive or when the pressure is not adequately distributed to a large enough area of brain.
This injury is thought to be the result of ischemia (inadequate blood flow) caused by the retraction, local trauma, or a combination of both.
It has been estimated that this type of brain retraction injury occurs in approximately 10% of major cranial base tumor procedures or 5% of intracranial aneurysm surgeries.
The specific aim of this research is to identify changes in electrical activity of brain tissue subjected to necessary retraction during neurosurgical procedures that may give forewarning of imminent brain retraction injury.
It is anticipated that this information will permit development of guidelines that will enable the neurosurgeon to take steps to minimize such injury, i.e., by temporarily releasing or otherwise modifying the brain retraction.
Cerebral electrical activity, together with the amount of retraction pressure being applied, will be recorded directly from the tissue at risk by means of a silastic electrode grid containing a pressure monitor placed on the surface of the cerebral cortex underneath the retractor blade.
Study Type
Interventional
Enrollment (Actual)
2
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Indiana
-
Indianapolis, Indiana, United States, 46206
- Methodist Hospital
-
-
Tennessee
-
Nashville, Tennessee, United States, 37232
- Vanderbilt University Medical Center
-
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Virginia
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Falls Church, Virginia, United States, 22042-3300
- Inova Fairfax Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- A patient must be scheduled to undergo skull base surgery requiring significant brain retraction
- Informed Consent
Exclusion Criteria:
- None, other than patients in whom major surgical complications are encountered that are unrelated to brain retraction may be excluded from subsequent data analysis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Brain Retraction Monitoring Sensor
|
This is a sensor incorporated into a brain retractor blade to monitor electrical activity and pressure applied to the brain during retraction required for the selected skull base operations.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Duration and intensity of brain retraction pressure
Time Frame: Intraoperative
|
Intraoperative
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cortical DC potential
Time Frame: Postoperative
|
Postoperative
|
Local Electrocorticography (ECoG)
Time Frame: Postoperative
|
Postoperative
|
Radiographic retraction injury
Time Frame: Postoperative
|
Postoperative
|
Clinical deficits
Time Frame: Postoperative
|
Postoperative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michael J Ayad, MD, PhD, Vanderbilt University Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2008
Primary Completion (Actual)
June 1, 2011
Study Completion (Actual)
June 1, 2011
Study Registration Dates
First Submitted
September 17, 2008
First Submitted That Met QC Criteria
September 17, 2008
First Posted (Estimate)
September 18, 2008
Study Record Updates
Last Update Posted (Actual)
September 15, 2017
Last Update Submitted That Met QC Criteria
September 14, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB 050960
- BRI IFH 04.073
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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