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

A Short Segment of a Single Dry EEG Electrode Allows the Digestive Endoscopy and Operating Theater Staff the Estimation of the Level of Anesthesia During Colonoscopy Sedation

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia; Adverse Effect
• Intervention / Treatment: Other: volunteer anesthesiologists and nurses

Detailed Description

Monitoring of the level of anesthesia has two primary functions: to reduce the incidence of awareness during operation and to avoid too deep anesthesia that is associated with increased risks of mortality and postoperative cognitive impairment. This monitoring can be performed by processed EEG such as "Bispectral Index" that provides a simple interpretation numerical value proportional to the anesthesia level. Nevertheless, "Bispectral index" requires specific tools and disposable material that increases costs for non operating room procedure. Colonoscopy is a non operating room procedure typically performed without or with light sedation, less frequently requires deep sedation. The latter is performed by using Propofol a drug that has a low therapeutic index and might be associated with adverse effects such as respiratory depression, aspiration related to loss of airway reflexes and hypotension. The aim of the present study is to evaluate the reliable interpretation of the raw EEG traces by a staff of digestive endoscopy and operating room for monitoring the level of sedation during non operative room anesthesia to avoid adverse effects.

• Study Type: Observational
• Enrollment (Actual): 26

Contacts and Locations

• Study Contact: Name: Alessandro Dr Tani, MD; Phone Number: 0393491384674; Email: alessandro.tani113@gmail.com

Study Locations

• Italy
  • Pisa
    • Volterra, Pisa, Italy, 56048
      • Santa Maria Maddalena Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• anesthesiologists and nursing staff of the operating room

Exclusion Criteria:

• specific knowledge of electroencephalography

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Azienda USL Toscana Nord Ovest
• Collaborators: Auxilium Vitae Volterra

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2023
• Primary Completion (Actual): January 18, 2023
• Study Completion (Actual): January 20, 2023

Study Registration Dates

• First Submitted: October 14, 2022
• First Submitted That Met QC Criteria: October 14, 2022
• First Posted (Actual): October 18, 2022

Study Record Updates

• Last Update Posted (Estimate): February 16, 2023
• Last Update Submitted That Met QC Criteria: February 15, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: raw EEG, colonoscopy sedation
• Other Study ID Numbers: AUSLNordOvest

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: the modalities of this option have not yet been decided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No