Brain Retraction Monitoring Sensor Study

NCT ID: NCT00754754

Last Updated: 2017-09-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2011-06-30

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.

Conditions

Brain Surgery Requiring Significant Retraction of the Brain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Brain Retraction Monitoring Sensor

Group Type: EXPERIMENTAL

Brain Retraction Monitoring Sensor

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael J Ayad, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Methodist Hospital

Indianapolis, Indiana, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Inova Fairfax Hospital

Falls Church, Virginia, United States

Countries

United States

Other Identifiers

BRI IFH 04.073

Identifier Type: -

Identifier Source: secondary_id

IRB 050960

Identifier Type: -

Identifier Source: org_study_id