Brain Retraction Monitoring Sensor Study
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Brain Surgery Requiring Significant Retraction of the Brain |
Device: Brain Retraction Monitoring Sensor |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Brain Retraction Monitoring Sensor |
- Duration and intensity of brain retraction pressure [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]
- Cortical DC potential [ Time Frame: Postoperative ] [ Designated as safety issue: No ]
- Local Electrocorticography (ECoG) [ Time Frame: Postoperative ] [ Designated as safety issue: No ]
- Radiographic retraction injury [ Time Frame: Postoperative ] [ Designated as safety issue: No ]
- Clinical deficits [ Time Frame: Postoperative ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | September 2008 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
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Device: Brain Retraction Monitoring Sensor
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Indiana | |
| Methodist Hospital | |
| Indianapolis, Indiana, United States, 46206 | |
| United States, Tennessee | |
| Vanderbilt University Medical Center | |
| Nashville, Tennessee, United States, 37232 | |
| United States, Virginia | |
| Inova Fairfax Hospital | |
| Falls Church, Virginia, United States, 22042-3300 | |
| Principal Investigator: | Michael J Ayad, MD, PhD | Vanderbilt University |
More Information
No publications provided
| Responsible Party: | Michael J. Ayad, MD, PhD, Vanderbilt University Medical Center |
| ClinicalTrials.gov Identifier: | NCT00754754 History of Changes |
| Other Study ID Numbers: | IRB 050960, BRI IFH 04.073 |
| Study First Received: | September 17, 2008 |
| Last Updated: | July 26, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Vanderbilt University:
|
brain surgery retraction injury monitoring |
ClinicalTrials.gov processed this record on June 17, 2013