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

Primary Purpose

Burst Suppression, General Anesthesia, Electroencephalogram

Status
Active
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
MATLAB-based interface, showing 50 EEG traces, classification of the EEG-pattern as Burst Suppression possible, yes, no.
Sponsored by
Technical University of Munich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Burst Suppression focused on measuring Intraoperative EEG based monitoring, Burst Suppression, EEG-signal characteristics, intraoperative monitoring, general anesthesia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • leading international experts in the field of intraoperative EEG analysis

Exclusion Criteria:

  • members of study group

Sites / Locations

  • Klinikum rechts der Isar - Klinik für Anästhesiologie und Intensivmedizin

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

MATLAB-based interface, showing 50 EEG traces

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Establishment of structures and working groups for the development of international definition criteria for Burst Suppression during general anesthesia.
International, validated definition criteria for Burst Suppression during general anesthesia (as a result of international expert knowledge).
Verification of the clinical applicability of the new definition criteria
Multi-stage coordination process; testing of the applicability in the subject-specific context and clinical routine.

Full Information

First Posted
August 10, 2022
Last Updated
September 29, 2022
Sponsor
Technical University of Munich
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1. Study Identification

Unique Protocol Identification Number
NCT05508386
Brief Title
Interrater Variability for the Identification of Anesthetic-induced Burst Suppression EEG
Official Title
Interrater Variability for the Identification of Anesthetic-induced Burst Suppression EEG
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 10, 2022 (Actual)
Primary Completion Date
November 15, 2022 (Anticipated)
Study Completion Date
April 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technical University of Munich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Intraoperative neuromonitoring is recommended to assess the level of general anesthesia. Additionally, specific intraoperative EEG patterns seem to be associated with PNDs. One of these EEG patterns is the burst suppression EEG. The pattern of waxing and waning activity has been associated with a higher risk factor for postoperative delirium. Commercial patient monitoring systems seem to underestimate the occurrence of Burst Suppression because the detection algorithms may not capture every suppression episode. A visual identification of this pattern is possible, but in the context of anesthesia monitoring, there is no standard definition of a Burst Suppression-EEG in the perioperative setting. Further, it displays unique clinical morphological characteristics. In particular, parameters of the EEG frequency spectrum are remarkably influenced by patients age and anesthetic agents. In order to agree on a definition for Burst Suppression during general anesthesia that will help to standardize Burst Suppression research and to optimize Burst Suppression monitoring, an expert consensus is essential. The planned project aims to pave the way to such a consensus of international expert societies in anesthesiology. Based on EEG data recorded within the framework of previous studies (approved Ethics application dated 20.08.2018 with number 246/18 S & 213/17S, dated 24.05.2017), the investigators will compose a representative data set (overall 50 EEG patterns) consisting of definitive Burst Suppression patterns (positive control), intraoperative EEG without Burst Suppression (negative control) and patterns that indicate different manifestations of a possible Burst Suppression-like pattern. The EEG recordings of this data set will be evaluated by selected international leading experts in EEG-based anesthesia monitoring. Therefore, a software environment (MATLAB) was developed, that allows the international experts to access the data set and score the traces pseudonymously. After the data sets have been scored, the interrater agreement for the single EEG episodes will be statistically analyzed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burst Suppression, General Anesthesia, Electroencephalogram
Keywords
Intraoperative EEG based monitoring, Burst Suppression, EEG-signal characteristics, intraoperative monitoring, general anesthesia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
pseudonymized interrater
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MATLAB-based interface, showing 50 EEG traces
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
MATLAB-based interface, showing 50 EEG traces, classification of the EEG-pattern as Burst Suppression possible, yes, no.
Intervention Description
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.
Primary Outcome Measure Information:
Title
To obtain expert knowledge that can help to introduce a clear definition of EEG features to identify anesthetic-induced Burst Suppression.
Description
Interrater variability for identification of Burst Suppression during general anesthesia.
Time Frame
2 months
Title
Investigation of spectral and time domain EEG features to assess objectively the individual raters scoring criteria.
Description
Spectral and time domain EEG features of the scored EEG sequences.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Establishment of structures and working groups for the development of international definition criteria for Burst Suppression during general anesthesia.
Description
International, validated definition criteria for Burst Suppression during general anesthesia (as a result of international expert knowledge).
Time Frame
5 years
Title
Verification of the clinical applicability of the new definition criteria
Description
Multi-stage coordination process; testing of the applicability in the subject-specific context and clinical routine.
Time Frame
5 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: leading international experts in the field of intraoperative EEG analysis Exclusion Criteria: members of study group
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefanie Pilge, PD Dr.
Organizational Affiliation
Senior Physician - Department of anesthesiology and intensive care
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Gerhard Schneider, Prof. Dr.
Organizational Affiliation
Clinic director - Department of anesthesiology and intensive care
Official's Role
Study Chair
Facility Information:
Facility Name
Klinikum rechts der Isar - Klinik für Anästhesiologie und Intensivmedizin
City
Munich
State/Province
Bavaria
ZIP/Postal Code
81675
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

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

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