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

Shanghai Jiao Tong University

Status: Completed

Conditions: Ultrasound-Guided Nerve Blocks; AI (Artificial Intelligence)

Treatments: Device: AI Annotation; Other: manual annotation

Study type: Interventional

Funder types: Other

Identifiers

NCT07171502

AI-Sacral Plexus

Details and patient eligibility

About

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.

Enrollment: 1,000 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,000 participants in 2 patient groups, including a placebo group

AI Annotation

Experimental group

Treatment:

Device: AI Annotation

Manual Annotation

Placebo Comparator group

Treatment:

Other: manual annotation