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

NCT05508386 | Unknown

• 1 other identifier: Burst Supp Identification
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Intraoperative EEG based monitoring; Burst Suppression; EEG-signal characteristics; intraoperative monitoring; general anesthesia

Outcome Measures

Primary Outcomes (2)

• To obtain expert knowledge that can help to introduce a clear definition of EEG features to identify anesthetic-induced Burst Suppression.

  Interrater variability for identification of Burst Suppression during general anesthesia.

  2 months

• Investigation of spectral and time domain EEG features to assess objectively the individual raters scoring criteria.

  Spectral and time domain EEG features of the scored EEG sequences.

  2 months

Secondary Outcomes (2)

• Establishment of structures and working groups for the development of international definition criteria for Burst Suppression during general anesthesia.

  5 years

• Verification of the clinical applicability of the new definition criteria

  5 years

Study Arms (1)

MATLAB-based interface, showing 50 EEG traces

OTHER

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.

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

Interventions

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

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.

MATLAB-based interface, showing 50 EEG traces

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• leading international experts in the field of intraoperative EEG analysis

You may not qualify if:

• members of study group

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (1)

Klinikum rechts der Isar - Klinik für Anästhesiologie und Intensivmedizin

Munich, Bavaria, 81675, Germany

Location

MeSH Terms

Interventions

YES1 protein, human

Study Officials

• Stefanie Pilge, PD Dr.

  Senior Physician - Department of anesthesiology and intensive care

  STUDY CHAIR

• Gerhard Schneider, Prof. Dr.

  Clinic director - Department of anesthesiology and intensive care

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: pseudonymized interrater
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2022
• First Posted: August 19, 2022
• Study Start: August 10, 2022
• Primary Completion: November 15, 2022
• Study Completion: April 1, 2023
• Last Updated: October 3, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)