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

NCT01256749 | Completed

• 1 other identifier: 5100294
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Correlation between 4 channel PSA EEG and a global 12 lead EEG

  The primary outcome measure is correlation between 4 channel frontal PSA EEG pattern and standard global 12 lead EEG during IBST.

  24 hours

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University

Loma Linda, California, 92354, United States

Location

Study Officials

• Deborah W McIvor, MD

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 2, 2010
• First Posted: December 9, 2010
• Study Start: December 1, 2010
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: September 9, 2014

Record last verified: 2014-09

Locations

US (1)