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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Loma Linda University

Loma Linda, California, United States, 92354