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AI-Assisted Ultrasound-Guided Nerve Block: Model Development and Performance Assessment

AI-Assisted Ultrasound-Guided Nerve Block: Model Development and Performance Assessment

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07171502
Acronym
AI
Enrollment
1000
Registered
2025-09-12
Start date
2025-09-30
Completion date
2025-12-31
Last updated
2026-01-06

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

Conditions

AI (Artificial Intelligence), Ultrasound-Guided Nerve Blocks

Brief summary

This study intends to have experts with over 10 years of experience in ultrasound-guided regional anesthesia acquire 1,000 target images. These images will be annotated by both an AI model and human experts, and the model's annotations will be evaluated by a panel of 10 specialists. The primary outcome is the accuracy of identifying the target anatomical structures in the annotated images. Secondary outcomes include the number of true positive, false positive, true negative, and false negative structures, the time required for annotation, and the potential application of the AI model in assisting the performance of ultrasound-guided regional blocks.

Interventions

DEVICEAI Annotation

Use the AI model to assist in annotating the target images.

OTHERmanual annotation

Use the manual to annotate the target images.

Sponsors

Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Aged 18-70 years * BMI between 19-23 kg·m-² * ASA physical status classification I-II * Normal orientation and able to cooperate with physical examination.

Exclusion criteria

* Patient refusal * Infection, trauma, skin defect, deformity, or other abnormalities at the intended nerve block site * Pregnancy

Design outcomes

Primary

MeasureTime frame
The accuracy of identifying the target anatomical structures in the annotated images.From enrollment to the end of treatment at 4 months

Secondary

MeasureTime frame
The number of false positive (FP) structuresFrom enrollment to the end of treatment at 4 months
The number of true negative (TN) structuresFrom enrollment to the end of treatment at 4 months
The number of true positive (TP) structuresFrom enrollment to the end of treatment at 4 months
The annotation time (time from the start to the end of annotation)From enrollment to the end of treatment at 4 months
An evaluation of the AI model if applied to assist in performing ultrasound-guided regional blocks: a) its impact on block failure rate (increase, no effect, decrease); b) its impact on the incidence of adverse events (increase, no effect, decrease)From enrollment to the end of treatment at 4 months
The number of false negative (FN) structuresFrom enrollment to the end of treatment at 4 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026