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Completed

NCT Number: NCT01256749

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

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.

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Key information

Conditions

Craniotomy Transphenoidal Pituitary Resection

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Loma Linda University

Loma Linda, California, 92354, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Dec 9, 2010
Registry last updated
Sep 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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