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

NCT ID: NCT01256749

Last Updated: 2014-09-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 31 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2013-11-30

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.

Conditions

Craniotomy; Transphenoidal Pituitary Resection

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Loma Linda University

OTHER

Sponsor Role: lead

Responsible Party

Deborah McIvor, MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Deborah W McIvor, MD

Role: PRINCIPAL_INVESTIGATOR

Loma Linda University

Locations

Loma Linda University

Loma Linda, California, United States

Countries

United States

Other Identifiers

5100294

Identifier Type: -

Identifier Source: org_study_id