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Brain Retraction Monitoring Sensor Study
This study is currently recruiting participants.
Verified by Vanderbilt University, September 2008
Sponsored by: Vanderbilt University
Information provided by: Vanderbilt University
ClinicalTrials.gov Identifier: NCT00754754
  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

U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Single Blind (Outcomes Assessor), Active Control, Single Group Assignment, Efficacy Study
Official Title: Brain Retraction Monitoring Sensor

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Duration and intensity of brain retraction pressure [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: 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.
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00754754

Contacts
Contact: Michael J Ayad, MD, PhD 615-343-3913 michael.ayad@vanderbilt.edu
Contact: Valerie A Sullenger, RN 615-343-9540 valerie.sullenger@vanderbilt.edu

Locations
United States, Indiana
Methodist Hospital Not yet recruiting
Indianapolis, Indiana, United States, 46206
Contact: Leisha Osburn, MS         LOsburn@clairan.org    
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Michael J Ayad, MD, PhD     615-343-3913     michael.ayad@vanderbilt.edu    
Contact: Valerie A Sullenger, RN     615-343-9540     valerie.sullenger@vanderbilt.edu    
Sub-Investigator: Robert A Mericle, MD            
Sub-Investigator: Kyle D Weaver, MD            
Sub-Investigator: Reid C Thompson, MD            
United States, Virginia
Inova Fairfax Hospital Not yet recruiting
Falls Church, Virginia, United States, 22042-3300
Contact: Eileen V Caulfield, RN, MA     703-776-4021     Eileen.Caulfield@inova.org    
Contact: Vivek Deshmukh, MD         vdeshmukh@mfa.gwu.edu    
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Michael J Ayad, MD, PhD Vanderbilt University
  More Information

Responsible Party: Vanderbilt University Medical Center ( Michael J. Ayad, MD, PhD )
Study ID Numbers: IRB 050960, BRI IFH 04.073
Study First Received: September 17, 2008
Last Updated: September 17, 2008
ClinicalTrials.gov Identifier: NCT00754754  
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
brain
surgery
retraction
injury
monitoring

ClinicalTrials.gov processed this record on January 13, 2009