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Brain Retraction Monitoring Sensor Study

Brain Retraction Monitoring Sensor

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00754754
Enrollment
2
Registered
2008-09-18
Start date
2008-09-30
Completion date
2011-06-30
Last updated
2017-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Surgery Requiring Significant Retraction of the Brain

Keywords

brain, surgery, retraction, injury, monitoring

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.

Interventions

PROCEDUREBrain 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.

Sponsors

Vanderbilt University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Duration and intensity of brain retraction pressureIntraoperative

Secondary

MeasureTime frame
Cortical DC potentialPostoperative
Local Electrocorticography (ECoG)Postoperative
Radiographic retraction injuryPostoperative
Clinical deficitsPostoperative

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026