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NCT00204711 Clinical Trial

Use of the SNAP II Electroencephalography (EEG) Monitor in Outpatients Undergoing Surgery/Procedures With Sedation

Sedation Clinical Trial

Official title:
Use of the SNAP II EEG Monitor in Outpatients Undergoing Surgery/Procedures With Sedation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00204711
Other study ID # H-2005-0014
Secondary ID SNAPII
Status Completed
Phase
First received
Last updated
Start date January 2005
Est. completion date November 2009

Study information
Verified date January 2019
Source University of Wisconsin, Madison
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to determine if the SNAP II electroencephalography (EEG) monitor accurately reflects changes in sedation level in outpatients undergoing surgery or procedures with sedation.

Recruitment information / eligibility
Status Completed
Enrollment 51
Est. completion date November 2009
Est. primary completion date November 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- American Society of Anesthesiologists (ASA) I, II or III physical status

Exclusion Criteria:

- Use of inhalation general anesthesia

- ASA IV physical status

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• SNAP II EEG System
A portable EEG monitor (SNAP II EEG System, Everest -St. Louis) is unique in that it monitors both low frequency EEG signals (1-40 Hz), which are typically used, and high frequency EEG signals (80-420 Hz), which are not usually used, and calculates a derived EEG parameter (the SNAP Index). The SNAP Index ranges from 100 (completely awake) to 0 (no brain activity) and has been shown in a few studies to correlate with increasing sedation and loss of consciousness in human volunteers and patients receiving general anesthesia during surgery.

Locations
Country Name City State
United States University of Wisconsin Hospital and Clinics Madison Wisconsin

Sponsors (1)
Lead Sponsor Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

References & Publications (1)

Springman SR, Andrei AC, Willmann K, Rusy DA, Warren ME, Han S, Lee M. A comparison of SNAP II and bispectral index monitoring in patients undergoing sedation. Anaesthesia. 2010 Aug;65(8):815-9. doi: 10.1111/j.1365-2044.2010.06408.x. Epub 2010 Jun 25. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Assessment of participant heterogeneity between SNAP Index and OASS Score. The SNAP Index is a derived EEG (electroencephalogram) parameter (from the SNAP II EEG System) ranging from 100 (completely awake) to 0 (no brain activity). The Observer's Assessment of Alertness/Sedation Score (OASS) is a score derived from motor and sensory functions between 0 and 5 where 0 is unresponsive and 5 is awake. up to 1 day post op
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