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Design and Development of Multi-modal Intelligent Anesthesia Monitoring System

Design and Development of Multi-modal Intelligent Anesthesia Monitoring System

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06317025
Enrollment
330
Registered
2024-03-19
Start date
2024-04-01
Completion date
2026-03-28
Last updated
2026-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Keywords

Anesthesia monitoring, Near infrared reflectance spectroscopy(NIRS), electroencephalogram(EEG), multimodal, Age dependent, Machine learning

Brief summary

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

Interventions

DIAGNOSTIC_TESTMulti-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)

Sponsors

Beijing Chao Yang Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
the depth of anesthesia (too deep or too shallow)During general anesthesiaPRST score system, combined with BIS index for comprehensive judgment

Secondary

MeasureTime frameDescription
EEG characteristics of loss of consciousness induced by different general anesthesia drugsDuring general anesthesiaSpectral Analysis,Connectivity Analysis,Brain Networks Analysis
Characteristics of perioperative neurovascular couplingPerioperativeEEG 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 9, 2026