GastritisNCT05545397
Sedation Level on Machine Learning With Electroencephalogram in Painless Gastroenteroscopy Patients
An observational study of Gastritis, run by General Hospital of Ningxia Medical University at 1 site in China.
Trial summary
Painless endoscopy technology can make patients comfortable under anesthesia, but because of the painless inside.The diagnosis and treatment time of endoscopic examination is short, and the transport is fast. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastritis
- What is being tested?
- Propofol and EEG montior
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2022to 31 Dec 2022
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who were eligible for this study were monitored by EEG, and propol was pumped at a rate of 600ml/h，MOAA/S was used to evaluate the depth of anesthesia. EEG was labeled, and the amount of propofol was recorded.The MATLAB software was used to analyze the EEG features, establish the classifier and establish the painless gastroenteroscopy of propofol induction dosage prediction model.
Who may be able to join
- Painless gastroenteroscopy patients
- ASA classification is Ⅰ-Ⅱ
- Patients who are willing to cooperate
- No schizophrenia,epilepsy and other neurological diseases
Who cannot join
- allergic to propofol
- Patients who are unwilling to cooperate
- Patients with psychiatric disorders
- Patients using sedative drugs for a long time
- Patients with neuropsychiatric disorders
- Patients with severe heart, liver, kidney and respiratory diseases
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ningxia Medical University Cardiovascular and Cerebrovascular Disease Hospital
Yinchuan, The Ningxia Hui Autonomous Region, 750021
Zhang Huiwen, 18709500998, zhanghuiwen1128@163.com
Ma Hanxiang, 13519591 598
About this study
Official title: Sedation Level Estimation Based on Machine Learning of Quantitative Occipital Electroencephalogram Features in Gastroenteroscopy Patients
Painless endoscopy technology can make patients comfortable under anesthesia, but because of the painless inside.The diagnosis and treatment time of endoscopic examination is short, and the transport is fast. Anesthesia related wind such as deep breathing depression and hypoxemia will occurRisks.Eeg depth monitoring can assist anesthesiologists to evaluate the depth of anesthesia and reduce the risk. Artificial intelligence is adopted.There are few reports on the evaluation of anesthesia depth and drug dosage by electroencephalogram (EEG) monitoring in outpatient patients with painless gastroenteroscopy.
Read the detailed description
1.examination, and establish brainClassification model of electrogram and sedation depth;2. The EEG characteristics, basic information and propofol were administered to all patients.The dose model of propofol painless gastroenteroscopy was established by machine learning to guide anesthesia Drug use;3. Evaluate the time and space complexity of the model, build the model, and assist the anesthesiologist to individualize the patient Chemical, safe and comfortable management.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
And pump propofol at a rate of 600ml/h. The degree of sedation was assessed by the MOAA/S scale until the depth sadation of the patient during the monitor of EEG
EEG montiorDevice
And pump propofol at a rate of 600ml/h. The degree of sedation was assessed by the MOAA/S scale until the depth sadation of the patient during the monitor of EEG
| Study group | Role | What they receive |
|---|---|---|
| The propofol group | Patients undergoing painless gastroenteroscopy under general anesthesia Receives: Drug: Propofol; Device: EEG montior |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electroencephalogram features
Time feature;frequency feature;Entropy
Measured: during gastroenteroscopy procedure
Propofol dosage
from awake to sedation in painless gastroenteroscopy
Measured: during gastroenteroscopy procedure
Secondary outcomes (8)
physiological parameter(blood pressure )
from awake to sedation in painless gastroenteroscopy with ECG monitor
Measured: during gastroenteroscopy procedure
physiological parameter(heart rate )
from awake to sedation in painless gastroenteroscopy with ECG monitor
Measured: during gastroenteroscopy procedure
physiological parameter(oxygen saturation )
from awake to sedation in painless gastroenteroscopy with ECG monitor
Measured: during gastroenteroscopy procedure
time parameter （Arousal times）
with monitor and Anesthesiologist's record
Measured: during endoscopy
success rate of once endoscopy
with monitor and Anesthesiologist's record
Measured: during endoscopy
Incidence of hypoxemia
with monitor and Anesthesiologist's record
Measured: during endoscopy
Endoscopist satisfaction by questionnaire
with monitor and Anesthesiologist's record
Measured: during endoscopy
vasoactive drugs
with monitor and Anesthesiologist's record
Measured: during endoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study start15 Sep 2022 (estimated)
- Primary completion30 Nov 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastritisStudies of the same condition, open and under way.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital of Ningxia Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05545397
- Sponsor's protocol ID
- Huiwen Zhang
- Status last verified
- Sep 2022
- First submitted
- 24 Aug 2022
- Last updated
- 21 Sep 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sedation Level Estimation Based on Machine Learning of Quantitative Occipital Electroencephalogram Features in Gastroenteroscopy Patients
- ClinicalTrials.gov ID
- NCT05545397
- Acronym / sponsor ID
- Huiwen Zhang
- Conditions
- Gastritis
- Keywords
- Deep Sedation, Machine learning, EEG characheristics;, Painless gastroscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- General Hospital of Ningxia Medical UniversityUniversity, hospital or other
- Study start
- 15 Sep 2022 (estimated)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 19 Sep 2022 (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.
Painless endoscopy technology can make patients comfortable under anesthesia, but because of the painless inside.The diagnosis and treatment time of endoscopic examination is short, and the transport is fast. Anesthesia related wind such as deep breathing depression and hypoxemia will occurRisks.Eeg depth monitoring can assist anesthesiologists to evaluate the depth of anesthesia and reduce the risk. Artificial intelligence is adopted.There are few reports on the evaluation of anesthesia depth and drug dosage by electroencephalogram (EEG) monitoring in outpatient patients with painless gastroenteroscopy.
Detailed description
1.examination, and establish brainClassification model of electrogram and sedation depth;2. The EEG characteristics, basic information and propofol were administered to all patients.The dose model of propofol painless gastroenteroscopy was established by machine learning to guide anesthesia Drug use;3. Evaluate the time and space complexity of the model, build the model, and assist the anesthesiologist to individualize the patient Chemical, safe and comfortable management.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The propofol group | – | Drug: Propofol, Device: EEG montiorPatients undergoing painless gastroenteroscopy under general anesthesia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were eligible for this study were monitored by EEG, and propol was pumped at a rate of 600ml/h，MOAA/S was used to evaluate the depth of anesthesia. EEG was labeled, and the amount of propofol was recorded.The MATLAB software was used to analyze the EEG features, establish the classifier and establish the painless gastroenteroscopy of propofol induction dosage prediction model.
Key inclusion criteria (4 listed)
- Painless gastroenteroscopy patients
- ASA classification is Ⅰ-Ⅱ
- Patients who are willing to cooperate
- No schizophrenia,epilepsy and other neurological diseases
Key exclusion criteria (6 listed)
- allergic to propofol
- Patients who are unwilling to cooperate
- Patients with psychiatric disorders
- Patients using sedative drugs for a long time
- Patients with neuropsychiatric disorders
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 |
|---|---|---|
| PropofolAnd pump propofol at a rate of 600ml/h. The degree of sedation was assessed by the MOAA/S scale until the depth sadation of the patient during the monitor of EEG | Drug | The propofol group |
| EEG montiorAnd pump propofol at a rate of 600ml/h. The degree of sedation was assessed by the MOAA/S scale until the depth sadation of the patient during the monitor of EEG | Device | The propofol group |
Primary outcome
Electroencephalogram features
Time frame: during gastroenteroscopy procedure
Time feature;frequency feature;Entropy
Propofol dosage
Time frame: during gastroenteroscopy procedure
from awake to sedation in painless gastroenteroscopy
8 secondary outcomes
physiological parameter(blood pressure )
Time frame: during gastroenteroscopy procedure
physiological parameter(heart rate )
Time frame: during gastroenteroscopy procedure
physiological parameter(oxygen saturation )
Time frame: during gastroenteroscopy procedure
time parameter （Arousal times）
Time frame: during endoscopy
success rate of once endoscopy
Time frame: during endoscopy
Incidence of hypoxemia
Time frame: during endoscopy
Endoscopist satisfaction by questionnaire
Time frame: during endoscopy
vasoactive drugs
Time frame: during endoscopy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
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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.
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 Gastritis, run by General Hospital of Ningxia Medical University 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 6 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: status not confirmed, as of the sponsor's last update on 21 Sep 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huiwen Zhang (18709500998, zhanghuiwen1128@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electroencephalogram features (time frame: during gastroenteroscopy procedure). The study lists 2 primary outcomes in all. 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 21 Sep 2022.