Ultrasound-guided Regional AnesthesiaNCT06546904
Artificial Intelligence Empowered Anesthesia Ultrasound Guided Regional Anesthesia Training
A study testing Artificial intelligence empowers anesthesia with ultrasound assistance in people with Ultrasound-guided Regional Anesthesia, run by Tongji Hospital at 1 site in China.
Trial summary
Evaluate the effectiveness of AI powered anesthesia ultrasound in ultrasound-guided regional anesthesia (UGRA) training. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Ultrasound-guided Regional Anesthesia
- What is being tested?
- Artificial intelligence empowers anesthesia with ultrasound assistance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2024to 31 Oct 2026
- Phase
- Interventional
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Voluntary participants;
- Sign the informed consent form.
Who cannot join
- allergic to ultrasound coupling agents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effectiveness of Artificial Intelligence Empowered Ultrasound in Regional Anesthesia Training
Evaluate the effectiveness of AI powered anesthesia ultrasound in ultrasound-guided regional anesthesia (UGRA) training.
Read the detailed description
The AI powered anesthesia ultrasound system integrates ScanNav and NeedleTrainer modules, providing real-time training for medical staff to simulate punctures. Combined with ScanNav's real-time anatomical structure recognition function, it is expected to significantly enhance the training effectiveness of ultrasound-guided regional anesthesia technology.
- Conditions
- Ultrasound-guided Regional Anesthesia
- Being tested
- Artificial intelligence empowers anesthesia with ultrasound assistance
- Keywords
- artificial intelligence, ultrasound-guided regional anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial intelligence empowers anesthesia with ultrasound assistanceDevice
Artificial intelligence empowers anesthesia with ultrasound assistance
| Study group | Role | What they receive |
|---|---|---|
| AI group | Experimental | Group AI used artificial intelligence to empower anesthesia ultrasound assisted simulated PNB operations in 5 areas Receives: Device: Artificial intelligence empowers anesthesia with ultrasound assistance |
| Control group | No intervention | Control group did not use AI assisted simulated PNB operations in 5 areas |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of ultrasound-guided puncture
Success rate of ultrasound-guided puncture at the first attempt
Measured: 1day
Secondary outcomes (1)
Location time
the time from the placement of the US transducer on the skin to the time of piercing of the skin.
Measured: 1day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start1 Sep 2024 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultrasound-guided Regional AnesthesiaStudies of the same condition, open and under way.
- More trials run by Tongji 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, aijun xu, Tongji Hospital
- Investigators
- mujun Chang, Dr., Study chair, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06546904
- Sponsor's protocol ID
- AISR
- Status last verified
- Aug 2024
- First submitted
- 3 Aug 2024
- Last updated
- 9 Aug 2024
- 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 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Artificial Intelligence Empowered Ultrasound in Regional Anesthesia Training
- ClinicalTrials.gov ID
- NCT06546904
- Acronym / sponsor ID
- AISR
- Conditions
- Ultrasound-guided Regional Anesthesia
- Keywords
- artificial intelligence, ultrasound-guided regional anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 9 Aug 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.
Evaluate the effectiveness of AI powered anesthesia ultrasound in ultrasound-guided regional anesthesia (UGRA) training.
Detailed description
The AI powered anesthesia ultrasound system integrates ScanNav and NeedleTrainer modules, providing real-time training for medical staff to simulate punctures. Combined with ScanNav's real-time anatomical structure recognition function, it is expected to significantly enhance the training effectiveness of ultrasound-guided regional anesthesia technology.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI group | Experimental | Device: Artificial intelligence empowers anesthesia with ultrasound assistanceGroup AI used artificial intelligence to empower anesthesia ultrasound assisted simulated PNB operations in 5 areas |
| Control group | No intervention | –Control group did not use AI assisted simulated PNB operations in 5 areas |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Voluntary participants;
- Sign the informed consent form.
Key exclusion criteria (1 listed)
- allergic to ultrasound coupling agents
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 |
|---|---|---|
| Artificial intelligence empowers anesthesia with ultrasound assistanceArtificial intelligence empowers anesthesia with ultrasound assistance | Device | AI group |
Primary outcome
Success rate of ultrasound-guided puncture
Time frame: 1day
Success rate of ultrasound-guided puncture at the first attempt
1 secondary outcome
Location time
Time frame: 1day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- 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.
mujun Chang, Dr. study chair
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artificial intelligence empowers anesthesia with ultrasound assistance in people with Ultrasound-guided Regional Anesthesia, run by Tongji 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 2 inclusion and 1 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 9 Aug 2024. 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 aijun Xu, Dr. (02783663625, 70663307@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of ultrasound-guided puncture (time frame: 1day). 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 9 Aug 2024.