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

NCT ID: NCT07171502

Last Updated: 2026-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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AI (Artificial Intelligence) Ultrasound-Guided Nerve Blocks

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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AI Annotation

Group Type EXPERIMENTAL

AI Annotation

Intervention Type DEVICE

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

Manual Annotation

Group Type PLACEBO_COMPARATOR

manual annotation

Intervention Type OTHER

Use the manual to annotate the target images.

Interventions

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AI Annotation

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

Intervention Type DEVICE

manual annotation

Use the manual to annotate the target images.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Jiao Tong University Affiliated Sixth People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Tao Xu

principal

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shanghai Sixth People's Hospital Affiliated with Shanghai Jiao Tong University School of Medicine

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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AI-Sacral Plexus

Identifier Type: -

Identifier Source: org_study_id

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