A Comparative Study of Global 12 Lead Electroencephalogram to Frontal SedlineTM Electroencephalogram

Completed

• Conditions: Craniotomy; Transphenoidal Pituitary Resection

• Registration Number: NCT01256749
• Lead Sponsor: Loma Linda University

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-02
• Study First Submitted QC: 2010-12-08
• Study First Posted: 2010-12-09
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-08
• Last Update Posted: 2014-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

1. Adult ASA class 1-3 male or female 18-90 years of age;
2. scheduled for elective craniotomy in the LLUMC University Hospital, for which the surgeon has requested intraoperative burst suppression therapy;
3. capable of understanding and signing informed consent;
4. willing to have dual EEG monitoring.

Exclusion Criteria

1. Age under 18 years;
2. emergency or trauma situation requiring craniotomy;
3. surgical approach that prohibits placing the SEDLineTM array on the forehead;
4. known sensitivity to the adhesives on the SEDLineTM array;
5. lack of availability of standard EEG monitoring;
6. patients with seizure disorders and refusal of consent.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between 4 channel PSA EEG and a global 12 lead EEG	24 hours	The primary outcome measure is correlation between 4 channel frontal PSA EEG pattern and standard global 12 lead EEG during IBST.

Trial Locations

Locations (1)

Loma Linda University; 🇺🇸 Loma Linda, California, United States