AnesthesiaNCT05569460
Construction of Perioperative Medical Data Platform and Its Typical Practice to Predict Postoperative Acute Moderate to Severe Pain With Machine Learning Models
An observational study of Anesthesia and Acute Pain, run by Guangdong Second Provincial General Hospital at 1 site in China.
Trial summary
Data intelligence platform was widely used to facilitate the process of clinical research. However, a platform that integrates natural language processing (NLP) and machine learning (ML) algorithms has not been reported in perioperative medical management. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Acute Pain, Risk Reduction
- How many people
- 6,500 participants
- Where
- 1 siteChina
- Study dates
- Oct 2022to Dec 2023
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pain assessment was used by Numeric Rating Scale (NRS) score after surgery.
Who may be able to join
- Patients were included if they were above 18 years old, undergoing non-local anesthesia surgery.
Who cannot join
- The basic information such gender, age, height, weight, and body mass index (BMI) were missing.
- Patients undergoing day surgery, with a history of multiple operations, or entering ICU after surgery, and losing the NRS score during movement at 24h after surgery.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangdong Second Provincial General Hospital
Guangzhou
Hui Zhang, 13719136792, zhanghui@gd2h.org.cn
About this study
Data intelligence platform was widely used to facilitate the process of clinical research. However, a platform that integrates natural language processing (NLP) and machine learning (ML) algorithms has not been reported in perioperative medical management.
- Conditions
- Anesthesia, Acute Pain, Risk Reduction
- Being tested
- No intervention
- Keywords
- Data Platform, Machine Learning, Postoperative Acute Pain
- Medical subject headings
- Acute Pain, Risk Reduction Behavior, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Numeric Rating Scale (NRS) score after surgery <4 | Not described Receives: Other: No intervention | |
| Numeric Rating Scale (NRS) score after surgery ≥ 4 | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve
It measures the prediction effect of the algorithm model
Measured: April 2020 to May 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study startOct 2022 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionDec 2023 (estimated)
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.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 6,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Second Provincial General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui Zhang, Guangdong Second Provincial General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05569460
- Sponsor's protocol ID
- Guangdong2nd
- Status last verified
- Oct 2022
- First submitted
- 3 Oct 2022
- Last updated
- 6 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction of Perioperative Medical Data Platform and Its Typical Practice to Predict Postoperative Acute Moderate to Severe Pain With Machine Learning Models
- ClinicalTrials.gov ID
- NCT05569460
- Acronym / sponsor ID
- Guangdong2nd
- Conditions
- Anesthesia, Acute Pain, Risk Reduction
- Keywords
- Data Platform, Machine Learning, Postoperative Acute Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6,500 participants (estimated)
- Lead sponsor
- Guangdong Second Provincial General HospitalUniversity, hospital or other
- Study start
- Oct 2022 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 6 Oct 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.
Data intelligence platform was widely used to facilitate the process of clinical research. However, a platform that integrates natural language processing (NLP) and machine learning (ML) algorithms has not been reported in perioperative medical management.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Numeric Rating Scale (NRS) score after surgery <4 | – | Other: No intervention |
| Numeric Rating Scale (NRS) score after surgery ≥ 4 | – | Other: No intervention |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pain assessment was used by Numeric Rating Scale (NRS) score after surgery.
Key inclusion criteria (1 listed)
- Patients were included if they were above 18 years old, undergoing non-local anesthesia surgery.
Key exclusion criteria (2 listed)
- The basic information such gender, age, height, weight, and body mass index (BMI) were missing.
- Patients undergoing day surgery, with a history of multiple operations, or entering ICU after surgery, and losing the NRS score during movement at 24h after surgery.
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 |
|---|---|---|
| No interventionNo intervention | Other | Numeric Rating Scale (NRS) score after surgery <4, Numeric Rating Scale (NRS) score after surgery ≥ 4 |
Primary outcome
Area under the curve
Time frame: April 2020 to May 2021
It measures the prediction effect of the algorithm model
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2022.
- Individual participant dataSharing planned: No
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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 Anesthesia and Acute Pain, run by Guangdong Second Provincial General 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 1 inclusion and 2 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 6 Oct 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve (time frame: April 2020 to May 2021). 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 6 Oct 2022.