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Brain Retraction Monitoring Sensor Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00754754
First Posted: September 18, 2008
Last Update Posted: September 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Vanderbilt University Medical Center ( Vanderbilt University )
  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 Procedure: Brain Retraction Monitoring Sensor

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Brain Retraction Monitoring Sensor

Further study details as provided by Vanderbilt University Medical Center ( Vanderbilt University ):

Primary Outcome Measures:
  • Duration and intensity of brain retraction pressure [ Time Frame: Intraoperative ]

Secondary Outcome Measures:
  • Cortical DC potential [ Time Frame: Postoperative ]
  • Local Electrocorticography (ECoG) [ Time Frame: Postoperative ]
  • Radiographic retraction injury [ Time Frame: Postoperative ]
  • Clinical deficits [ Time Frame: Postoperative ]

Enrollment: 2
Study Start Date: September 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Brain Retraction Monitoring Sensor Procedure: 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00754754


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
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Michael J Ayad, MD, PhD Vanderbilt University Medical Center
  More Information

Responsible Party: Vanderbilt University
ClinicalTrials.gov Identifier: NCT00754754     History of Changes
Other Study ID Numbers: IRB 050960
BRI IFH 04.073
First Submitted: September 17, 2008
First Posted: September 18, 2008
Last Update Posted: September 15, 2017
Last Verified: September 2017

Keywords provided by Vanderbilt University Medical Center ( Vanderbilt University ):
brain
surgery
retraction
injury
monitoring