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

Craniotomy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01256749
• Other study ID #: 5100294
• Status: Completed
• Phase: N/A
• First received: December 2, 2010
• Last updated: September 8, 2014
• Start date: December 2010
• Est. completion date: November 2013

Study information

• Verified date: September 2014
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Craniotomy
• Pituitary Diseases
• Transphenoidal Pituitary Resection

Locations

Country	Name	City	State
United States	Loma Linda University	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No