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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01256749

Enrollment

Registered

2010-12-09

Start date

2010-12-31

Completion date

2013-11-30

Last updated

2014-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Craniotomy, Transphenoidal Pituitary Resection

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Correlation between 4 channel PSA EEG and a global 12 lead EEG	24 hours	The primary outcome measure is correlation between 4 channel frontal PSA EEG pattern and standard global 12 lead EEG during IBST.

Countries

United States

Outcome results