Design and Development of Multi-modal Intelligent Anesthesia Monitoring System

NCT ID: NCT06317025

Last Updated: 2025-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

330 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-01

Study Completion Date

2025-05-01

Brief Summary

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This project integrates the characteristics of electroencephalo-graph(EEG), cerebral oxygen, blood pressure, heart rate, etc., based on nonlinear theory and neural oscillation, large sample data and machine learning theory, to develop a multi-modal monitoring system suitable for domestic patients, taking into account changes in sedation, analgesia, cerebral hemodynamics and other factors, regardless of patient age and type of general anesthesia drugs.

Detailed Description

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Conditions

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Anesthesia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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General anaesthetic patient

Monitoring depth of anaesthesia using PRST (P:pressure, T:tear,R:rate, S:sweat)score developed by Evans and bispectral index

Multi-modal Intelligent Anesthesia Monitoring System

Intervention Type DIAGNOSTIC_TEST

To evaluate the sensitivity and specificity of self-developed anesthesia monitoring systems in diagnosing the depth of anesthesia (too deep or too shallow)

Interventions

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Multi-modal Intelligent Anesthesia Monitoring System

To evaluate the sensitivity and specificity of self-developed anesthesia monitoring systems in diagnosing the depth of anesthesia (too deep or too shallow)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. Age: 0-65 years old
2. ASA: Level I-III
3. Patients undergoing non cardiac surgery under general anesthesia
4. Informed consent of the patient or legal representative

Exclusion Criteria

1. Previous history of severe neurological disorders
2. History of mental illness and related medication use
3. Individuals who are unable to cooperate in completing cognitive function tests
4. Severe hearing or visual impairment
5. Preoperative delirium in patients
6. Individuals who have experienced severe adverse reactions such as cardiac arrest and cardiopulmonary resuscitation during surgery
7. Those who require neurosurgery, head and facial surgery
8. Individuals who are allergic to EEG and fNIRS electrodes
Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Chao Yang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Anesthesiology, Beijing Chaoyang Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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SHOUFA2022-2Z-2039

Identifier Type: -

Identifier Source: org_study_id

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