A Comparative Study of Global 12 Lead Electroencephalogram to Frontal SedlineTM Electroencephalogram
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Deborah McIvor, MD, Loma Linda University
First received: December 2, 2010
Last updated: August 6, 2013
Last verified: August 2013
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 determine if a less expensive, less invasive and possibly more convenient bifrontal EEG monitor can be effective for evaluation of anesthesia-induced intraoperative burst suppression therapy (IBST) for cerebral protection.
Transphenoidal Pituitary Resection
||Observational Model: Case-Only
Time Perspective: Prospective
||A Comparative Study of Global 12 Lead Electroencephalogram to Frontal SedlineTM Electroencephalogram Monitoring for the Evaluation of Intraoperative Burst Suppression During Elective Craniotomy or Transphenoidal Pituitary Resection
Primary Outcome Measures:
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||November 2013 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years to 90 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Adult patients scheduled for elective craniotomy or transphenoidal pituitary resection at LLUMC University Hospital in which the surgeon has requested intraoperative burst suppression therapy regardless of the inciting etiology will be eligible to participate in this study.
- 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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01256749
|Loma Linda University
|Loma Linda, California, United States, 92354 |
Loma Linda University
||Deborah W McIvor, MD
||Loma Linda University
No publications provided
ClinicalTrials.gov processed this record on July 26, 2014
||Deborah McIvor, MD, MD, Loma Linda University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 2, 2010
||August 6, 2013
||United States: Institutional Review Board