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

This study has been completed.
Information provided by (Responsible Party):
Deborah McIvor, MD, Loma Linda University Identifier:
First received: December 2, 2010
Last updated: September 8, 2014
Last verified: September 2014
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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Loma Linda University:

Primary Outcome Measures:
  • Correlation between 4 channel PSA EEG and a global 12 lead EEG [ Time Frame: 24 hours ]
    The primary outcome measure is correlation between 4 channel frontal PSA EEG pattern and standard global 12 lead EEG during IBST.

Enrollment: 31
Study Start Date: December 2010
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01256749

United States, California
Loma Linda University
Loma Linda, California, United States, 92354
Sponsors and Collaborators
Loma Linda University
Principal Investigator: Deborah W McIvor, MD Loma Linda University
  More Information

Responsible Party: Deborah McIvor, MD, MD, Loma Linda University Identifier: NCT01256749     History of Changes
Other Study ID Numbers: 5100294
Study First Received: December 2, 2010
Last Updated: September 8, 2014

Additional relevant MeSH terms:
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases processed this record on May 22, 2017