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Completed

NCT Number: NCT00754754

Brain Retraction Monitoring Sensor Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Methodist Hospital, Indianapolis, Indiana, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brain Retraction Monitoring Sensor

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.

Primary outcomes

  1. Duration and intensity of brain retraction pressure

    Time frame: Intraoperative

Secondary outcomes

  1. Cortical DC potential

    Time frame: Postoperative

  2. Local Electrocorticography (ECoG)

    Time frame: Postoperative

  3. Radiographic retraction injury

    Time frame: Postoperative

  4. Clinical deficits

    Time frame: Postoperative

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Registry information

Official study title

Brain Retraction Monitoring Sensor

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Sep 18, 2008
Registry last updated
Sep 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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