Clinical trial NCT00754754: Brain Retraction Monitoring Sensor Study
Official title: Brain Retraction Monitoring Sensor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Surgery Requiring Significant Retraction of the Brain
Keywords: brain
surgery
retraction
injury
monitoring
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2008-09-18
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Duration and intensity of brain retraction pressure
timeFrame: Intraoperative
Secondary outcomes:
measure: Cortical DC potential
timeFrame: Postoperative
measure: Local Electrocorticography (ECoG)
timeFrame: Postoperative
measure: Radiographic retraction injury
timeFrame: Postoperative
measure: Clinical deficits
timeFrame: Postoperative
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Methodist Hospital
state: Indiana
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
Study officials:
affiliation: Vanderbilt University Medical Center
name: Michael J Ayad, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: