Composite Nociception Index Using EEG, ECG, and ICG Signals

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Solution Overview

Problem

Current methods for monitoring nociception and analgesia during anesthesia are inadequate, often relying on non-specific autonomic responses and failing to provide objective, real-time measures, leading to potential intraoperative awareness and postoperative psychosomatic dysfunction.

Innovation Solution

A multi-parameter approach combining EEG, facial EMG, HRV, and ICG data to calculate a Composite Nociception Index (CNI) using FFT, Hilbert transform, and Choi-Williams distributions, which provides a more objective and reliable assessment of nociception and analgesia levels.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If a single parameter method (e.g., Ramsay scale) is used to assess nociception, then the device complexity is low, but the measurement precision and reliability are insufficient

Engineering Contradiction:
Improvenociception assessment accuracyVSAvoidmonitoring system complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent combines multiple monitoring parameters (EEG, EMG, ECG, ICG, respiratory rate, blood pressure, oxygen saturation) into a unified nociception assessment system. The processing unit integrates signals from different physiological systems to generate a comprehensive nociception index, thereby improving measurement precision while managing system complexity through systematic integration.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The monitoring system is designed to perform multiple functions simultaneously: it monitors consciousness level (EEG), muscle activity (EMG), cardiac function (ECG, ICG), respiratory status, and nociception response. This multi-functional approach allows a single system to provide comprehensive anesthesia monitoring without requiring separate specialized devices for each parameter.

Inventive Principle:
Principle #6Universality (Multi-functionality)

2Reliability

If multiple parameters are combined to improve nociception assessment, then the measurement precision improves, but the device complexity increases

Engineering Contradiction:
Improveanalgesia monitoring reliabilityVSAvoidmulti-parameter system complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The system continuously monitors multiple physiological parameters and provides real-time feedback through the nociception index display. The processing unit analyzes incoming signals from EEG, EMG, ECG, ICG and other sensors, processes them through established algorithms, and immediately updates the nociception assessment, allowing dynamic adjustment of analgesia based on actual patient response.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The system automatically processes and integrates multiple physiological signals without requiring manual intervention for each parameter. The processing unit autonomously performs signal integration, noise filtering, and nociception index calculation, reducing the operational burden on anesthesia providers while maintaining high reliability through continuous automated monitoring.

Inventive Principle:
Principle #25Self-service

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

The method offers a safer and more accurate monitoring of nociception and analgesia, reducing the risk of intraoperative awareness and postoperative complications by providing a continuous, non-invasive, and objective measure of pain and analgesia levels.

Implementation Method 1

means adapted for obtaining a signal containing electroencephalogram (EEG) and facial electromyogram (EMG) from a subjects scalp with three electrodes positioned at middle forehead, left (right) forehead and the left (right) cheek

Methodology Applied
Scientific EffectElectroencephalography:

Implementation Method 2

means adapted for obtaining a three leads electrocardiogram (ECG) signal and adaptations for calculating the R-R interval and the heart rate variability (HRV) from said ECG signal

Methodology Applied
Scientific EffectElectrocardiography:

Implementation Method 3

means adapted for obtaining an impedance cardiography (ICG) signal with four electrodes positioned at the chest of the patient; means adapted for obtaining the plethysmographic from the impedance cardiography (ICG)

Methodology Applied
Scientific EffectImpedance cardiography: Electrical Impedance Tomography

Implementation Method 4

adaptations for calculating the Fast Fourier Transform (FFT) and the Choi-Williams distributions for about 1-60 seconds of the EEG signal

Methodology Applied
Scientific EffectFast Fourier Transform:

Implementation Method 5

adaptations for calculating the Hilbert transform of the ICG signal from which the number of peaks over a certain threshold in the 1st derivative of the Hilbert phase, is estimated

Methodology Applied
Scientific EffectHilbert transform:

Data Source

PatentEP3232917B1Apparatus for the assessment of the level of pain and nociception during general anesthesia using electroencephalogram, plethysmographic impedance cardiography, heart rate variability and the concentration or biophase of the analgesics
Publication Date: 2019.09.18 QUANTIUM MEDICAL SL
  • EP3232917B1 patent drawingFigure 1
  • EP3232917B1 patent drawingFigure 2
  • EP3232917B1 patent drawingFigure 3

AI summary

Means and methods for measuring pain and adapted for calculating the level of nociception during general anesthesia or sedation from data including electroencephalogram (EEG), facial electromyogram (EMG), heart rate variability (HRV) by electrocardiogram (ECG) and plethysmography by impedance cardiography (ICG). In a preferred embodiment of this invention the parameters derived from the EEG, the HRV, the plethysmographic curve and the analgetics concentrations are either combined into one index on a scale from 0 to 100, where a high number is associated with high probability of response to noxious stimuli, while a decreasing index is associated with decreasing probability of response to noxious stimuli. Zero (0) indicates extremely low probability of response to noxious stimuli. In an alternative embodiment, only features from the EEG and ECG will be used or only features from EEG, ECG and ICG, to define the final index.