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Interrater Variability for the Identification of Anesthetic-induced Burst Suppression EEG

NCT05508386 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-10-03

No results posted yet for this study

Summary

Burst suppression describes a specific EEG pattern that can generally indicate a too deep general anesthesia. The pathophysiology of anesthetic-induced Burst Suppression may be distinctly different from the pathophysiology of Burst Suppression from other medical causes (e.g., coma, hypothermia, intoxication). Definition criteria of neurologic societies cannot be applied to the classification of Burst Suppression during general anesthesia without adaptation. The lack of a clear definition complicates structured research on anesthetic-induced Burst Suppression EEG in the perioperative setting because of subjective bias. Therefore, a unified agreement on what anesthesia-induced Burst Suppression looks like is crucial to conduct the best possible research. The aim of this study is to formulate the basis for a clear definition of burst suppression EEG that may help to truly understand the significance of this EEG pattern and its relationship to proposed postoperative outcomes such as postoperative delirium, longterm postoperative neurocognitive disorders (PNDs) or increased mortality.

Conditions

  • Burst Suppression
  • General Anesthesia
  • Electroencephalogram

Interventions

OTHER

MATLAB-based interface, showing 50 EEG traces, classification of the EEG-pattern as Burst Suppression possible, yes, no.

A software environment (MATLAB) was developed, that allows the international experts to access the data set and score the traces pseudonymously. This MATLAB-based interface shows 50 EEG traces. A representative dataset was composed, consisting of definite Burst Suppression patterns (positive control), intraoperative EEG without Burst Suppression patterns (negative control), and patterns indicating different manifestations of a possible Burst Suppression-like pattern.

Sponsors & Collaborators

  • Technical University of Munich

    lead OTHER

Principal Investigators

  • Stefanie Pilge, PD Dr. · Senior Physician - Department of anesthesiology and intensive care

  • Gerhard Schneider, Prof. Dr. · Clinic director - Department of anesthesiology and intensive care

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-10
Primary Completion
2022-11-15
Completion
2023-04-01

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05508386 on ClinicalTrials.gov