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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01256749
Recruitment Status : Completed
First Posted : December 9, 2010
Last Update Posted : September 9, 2014
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Craniotomy Transphenoidal Pituitary Resection

Study Design

Study Type : Observational
Actual Enrollment : 31 participants
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
Study Start Date : December 2010
Primary Completion Date : November 2013
Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. 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.

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
ClinicalTrials.gov Identifier: NCT01256749     History of Changes
Other Study ID Numbers: 5100294
First Posted: December 9, 2010    Key Record Dates
Last Update Posted: September 9, 2014
Last Verified: September 2014

Additional relevant MeSH terms:
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases