Design and Development of Multi-modal Intelligent Anesthesia Monitoring System

September 8, 2025 updated by: Beijing Chao Yang Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

330

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100020
        • Department of Anesthesiology, Beijing Chaoyang Hospital, Capital Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing non-cardiac surgery under general anesthesia in Beijing Chaoyang Hospital, Capital Medical University

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
General anaesthetic patient
Monitoring depth of anaesthesia using PRST （P：pressure， T：tear，R：rate， S：sweat）score developed by Evans and bispectral index
Diagnostic test: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the depth of anesthesia (too deep or too shallow)
Time Frame: During general anesthesia
PRST score system, combined with BIS index for comprehensive judgment
During general anesthesia

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EEG characteristics of loss of consciousness induced by different general anesthesia drugs
Time Frame: During general anesthesia
Spectral Analysis，Connectivity Analysis，Brain Networks Analysis
During general anesthesia
Characteristics of perioperative neurovascular coupling
Time Frame: Perioperative
EEG power and entropy indexes are extracted by moving window method as new time series, and a new time series consistent with NIRS is constructed. The entropy and power of different frequency bands after resampling were used as the indexes of neural activity, and ΔHbO and ΔHb were selected as the indexes of hemodynamic activity. The neurovascular coupling was evaluated by calculating the coherence of neural activity and hemodynamic activity.
Perioperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Chao Yang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Actual)

May 1, 2025

Study Completion (Actual)

May 1, 2025

Study Registration Dates

First Submitted

February 21, 2024

First Submitted That Met QC Criteria

March 17, 2024

First Posted (Actual)

March 19, 2024

Study Record Updates

Last Update Posted (Estimated)

September 12, 2025

Last Update Submitted That Met QC Criteria

September 8, 2025

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHOUFA2022-2Z-2039

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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