Status:
COMPLETED
A Comparative Study of Global 12 Lead Electroencephalogram to Frontal SedlineTM Electroencephalogram
Lead Sponsor:
Loma Linda University
Conditions:
Craniotomy
Transphenoidal Pituitary Resection
Eligibility:
All Genders
18-90 years
Brief Summary
The fundamental reason for comparing the ability of the Frontal Sedline TM Electroencephalogram (PSA EEG) to standard Global 12 Lead Electroencephalogram (EEG) for burst suppression detection is to de...
Eligibility Criteria
Inclusion
- Adult ASA class 1-3 male or female 18-90 years of age;
- scheduled for elective craniotomy in the LLUMC University Hospital, for which the surgeon has requested intraoperative burst suppression therapy;
- capable of understanding and signing informed consent;
- willing to have dual EEG monitoring.
Exclusion
- Age under 18 years;
- emergency or trauma situation requiring craniotomy;
- surgical approach that prohibits placing the SEDLineTM array on the forehead;
- known sensitivity to the adhesives on the SEDLineTM array;
- lack of availability of standard EEG monitoring;
- patients with seizure disorders and refusal of consent.
Key Trial Info
Start Date :
December 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT01256749
Start Date
December 1 2010
End Date
November 1 2013
Last Update
September 9 2014
Active Locations (1)
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1
Loma Linda University
Loma Linda, California, United States, 92354