A Single Dry EEG Electrode Allows to Estimate of the Level of Anesthesia During Colonoscopy Sedation.

NCT05584904 | Completed

• 1 other identifier: AUSLNordOvest
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

We asked to a staff of digestive endoscopy and of the operating room to interpret the EEG traces obtained from a single dry electrode device to estimate the level of anesthesia during colonoscopy. They are required to produce a rank value (1 to 3) proportional to the anesthesia level. The rank values of anesthesia evaluated through the EEG traces will be correlated to the typically used "bispectral index" values simultaneously acquired. The expected efficacy of a low-cost single dry-electrode EEG would allow the monitoring of the level of anesthesia during non operating room procedures such as colonoscopy.

Conditions

Anesthesia; Adverse Effect

Keywords

raw EEG, colonoscopy sedation

Outcome Measures

Primary Outcomes (1)

• Single dry channel EEG for the monitoring of the level of anesthesia in non-operating room.

  A staff of digestive endoscopy and operating room after attending a brief course of EEG specifically direct to anesthesia level interpretation, were asked to classify the raw EEG trace obtained with a sigle dry electrode device in 3 levels (1 to 3) according to the following category: 1 deep sedation, , 2 intermediate state, 3 light sedation or awake according to the BIS level and and coherent with clinical conditions. We correlate staff scores produced by classifing the EEG trace with the number automatically and simultaneously produced by the "bispectral index" tool for the measurement of the level of anesthesia. The reliability of raw single dry electrode EEG trace, might allow to assist low-cost device for non operating room anesthesia such as for colonoscopy sedation.

  two hours

Interventions

volunteer anesthesiologists and nurses OTHER

18 not expert in electroencephalography digestive endoscopy and operating room nurses, and 8 anesthesiologists interpreting EEGs obtained with a single electrode EEG

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All the anesthesiologists and nursing staff of the digestive endoscopy and operating room of the Volterra Hospital

You may qualify if:

• anesthesiologists and nursing staff of the operating room

You may not qualify if:

• specific knowledge of electroencephalography

Sponsors & Collaborators

• Azienda USL Toscana Nord Ovest: lead
• Auxilium Vitae Volterra: collaborator

Study Sites (1)

Santa Maria Maddalena Hospital

Volterra, Pisa, 56048, Italy

Location

Related Publications (1)

• Barnard JP, Bennett C, Voss LJ, Sleigh JW. Can anaesthetists be taught to interpret the effects of general anaesthesia on the electroencephalogram? Comparison of performance with the BIS and spectral entropy. Br J Anaesth. 2007 Oct;99(4):532-7. doi: 10.1093/bja/aem198. Epub 2007 Jul 24.

  PMID: 17652076 BACKGROUND

MeSH Terms

Interventions

Nurses

Intervention Hierarchy (Ancestors)

Health Personnel; Health Care Facilities Workforce and Services

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of perioperative medicine and pain therapy Volterra Hospital

Study Record Dates

• First Submitted: October 14, 2022
• First Posted: October 18, 2022
• Study Start: January 13, 2023
• Primary Completion: January 18, 2023
• Study Completion: January 20, 2023
• Last Updated: February 16, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)