AnesthesiaNCT06317025
Design and Development of Multi-modal Intelligent Anesthesia Monitoring System
An observational study of Anesthesia, run by Beijing Chao Yang Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 0 to 65 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Multi-modal Intelligent Anesthesia Monitoring System
- How many people
- 330 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2024to 28 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing non-cardiac surgery under general anesthesia in Beijing Chaoyang Hospital, Capital Medical University
Who may be able to join
- Age: 0-65 years old
- ASA: Level I-III
- Patients undergoing non cardiac surgery under general anesthesia
- Informed consent of the patient or legal representative
Who cannot join
- Previous history of severe neurological disorders
- History of mental illness and related medication use
- Individuals who are unable to cooperate in completing cognitive function tests
- Severe hearing or visual impairment
- Preoperative delirium in patients
- Individuals who have experienced severe adverse reactions such as cardiac arrest and cardiopulmonary resuscitation during surgery
- Those who require neurosurgery, head and facial surgery
- Individuals who are allergic to EEG and fNIRS electrodes
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Anesthesiology, Beijing Chaoyang Hospital, Capital Medical University
Beijing, Beijing Municipality, 100020
About this study
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.
- Conditions
- Anesthesia
- Being tested
- Multi-modal Intelligent Anesthesia Monitoring System
- Keywords
- Anesthesia monitoring, Near infrared reflectance spectroscopy（NIRS）, electroencephalogram（EEG）, multimodal, Age dependent, Machine learning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-modal Intelligent Anesthesia Monitoring SystemDiagnostic test
To evaluate the sensitivity and specificity of self-developed anesthesia monitoring systems in diagnosing the depth of anesthesia (too deep or too shallow)
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing general anaesthesia who were prospectively enrolled for multimodal physiological | Monitoring depth of anaesthesia using PRST （P：pressure， T：tear，R：rate， S：sweat）score developed by Evans and bispectral index Receives: Diagnostic Test: Multi-modal Intelligent Anesthesia Monitoring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
the depth of anesthesia (too deep or too shallow)
PRST score system, combined with BIS index for comprehensive judgment
Measured: During general anesthesia
Secondary outcomes (2)
EEG characteristics of loss of consciousness induced by different general anesthesia drugs
Spectral Analysis，Connectivity Analysis，Brain Networks Analysis
Measured: During general anesthesia
Characteristics of perioperative neurovascular coupling
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.
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start1 Apr 2024
- Primary completion28 Mar 2026
- Study completion28 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Beijing Chao Yang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06317025
- Sponsor's protocol ID
- SHOUFA2022-2Z-2039
- Status last verified
- Sep 2026
- First submitted
- 21 Feb 2024
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the published results may be made available to qualified researchers upon reasonable request to the corresponding author, subject to institutional approval, ethics requirements, and applicable data-protection regulations.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design and Development of Multi-modal Intelligent Anesthesia Monitoring System
- ClinicalTrials.gov ID
- NCT06317025
- Acronym / sponsor ID
- SHOUFA2022-2Z-2039
- Conditions
- Anesthesia
- Keywords
- Anesthesia monitoring, Near infrared reflectance spectroscopy（NIRS）, electroencephalogram（EEG）, multimodal, Age dependent, Machine learning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 28 Mar 2026 (actual)
- Study completion
- 28 Mar 2026 (actual)
- First posted
- 19 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing general anaesthesia who were prospectively enrolled for multimodal physiological | – | Diagnostic Test: Multi-modal Intelligent Anesthesia Monitoring SystemMonitoring depth of anaesthesia using PRST （P：pressure， T：tear，R：rate， S：sweat）score developed by Evans and bispectral index |
Who may qualify
- Ages
- 0 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing non-cardiac surgery under general anesthesia in Beijing Chaoyang Hospital, Capital Medical University
Key inclusion criteria (4 listed)
- Age: 0-65 years old
- ASA: Level I-III
- Patients undergoing non cardiac surgery under general anesthesia
- Informed consent of the patient or legal representative
Key exclusion criteria (8 listed)
- Previous history of severe neurological disorders
- History of mental illness and related medication use
- Individuals who are unable to cooperate in completing cognitive function tests
- Severe hearing or visual impairment
- Preoperative delirium in patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-modal Intelligent Anesthesia Monitoring SystemTo evaluate the sensitivity and specificity of self-developed anesthesia monitoring systems in diagnosing the depth of anesthesia (too deep or too shallow) | Diagnostic test | Patients undergoing general anaesthesia who were prospectively enrolled for multimodal physiological |
Primary outcome
the depth of anesthesia (too deep or too shallow)
Time frame: During general anesthesia
PRST score system, combined with BIS index for comprehensive judgment
2 secondary outcomes
EEG characteristics of loss of consciousness induced by different general anesthesia drugs
Time frame: During general anesthesia
Characteristics of perioperative neurovascular coupling
Time frame: Perioperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the published results may be made available to qualified researchers upon reasonable request to the corresponding author, subject to institutional approval, ethics requirements, and applicable data-protection regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, run by Beijing Chao Yang Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the depth of anesthesia (too deep or too shallow) (time frame: During general anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.