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Clinical Trials/NCT07532278
NCT07532278
Not yet recruiting
Not Applicable

Evaluation of Agreement Between Artificial Intelligence and Experienced Anesthesiologists in Target Point Identification for Ultrasound-Guided Axillary Brachial Plexus Block: A Prospective Observational Study

Gaziantep City Hospital0 sites100 target enrollmentStarted: April 15, 2026Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Gaziantep City Hospital
Enrollment
100
Primary Endpoint
Agreement in Target Point Identification Between Artificial Intelligence and Anesthesiologists

Overview

Brief Summary

This prospective observational study aims to evaluate the agreement between artificial intelligence (AI)-assisted target point identification and experienced anesthesiologists during ultrasound-guided axillary brachial plexus block.

Ultrasound guidance is widely used in regional anesthesia to improve block success and safety. However, accurate identification of anatomical structures and optimal injection points remains operator-dependent. Artificial intelligence-based systems have the potential to assist clinicians by identifying anatomical landmarks in real time.

In this study, AI-generated target points will be compared with those determined by experienced anesthesiologists. The level of agreement between the two methods will be analyzed. Secondary outcomes will include block performance parameters and image quality.

The findings of this study may contribute to understanding the clinical utility of AI in ultrasound-guided regional anesthesia.

Detailed Description

Ultrasound-guided axillary brachial plexus block is a widely used regional anesthesia technique for upper extremity surgeries. The success of the procedure largely depends on accurate identification of neural structures and optimal injection points, which are operator-dependent.

Artificial intelligence (AI) has recently emerged as a promising tool for assisting ultrasound interpretation by automatically identifying anatomical structures. However, the level of agreement between AI-based target point identification and expert anesthesiologists has not been sufficiently investigated, particularly in axillary brachial plexus block.

In this prospective observational study, patients undergoing upper extremity surgery under axillary brachial plexus block will be included. No additional intervention will be performed on patients within the scope of the study. All evaluations will be based on real-time ultrasound imaging obtained as part of routine clinical practice.

During routine ultrasound examination prior to block performance, images will be observed in real time. Experienced anesthesiologists will determine anatomical structures and optimal target injection points during the procedure. Simultaneously, the AI-based system will analyze the same real-time ultrasound images and identify target points.

For each identified nerve (median, ulnar, radial, and musculocutaneous), both AI and anesthesiologists will determine target injection points. The spatial difference between AI-generated and expert-defined target points will be calculated in millimeters.

The primary objective is to evaluate the agreement between AI and anesthesiologists in target point identification using the intraclass correlation coefficient (ICC). Additionally, a difference of ≤5 mm between measurements will be considered clinically acceptable agreement.

Secondary outcomes will include:

Proportion of measurements within ≤5 mm agreement Agreement in nerve identification Procedure-related parameters

All expert evaluations will be performed independently and blinded to AI outputs.

This study aims to determine whether AI can reliably assist clinicians in identifying anatomical targets during ultrasound-guided regional anesthesia without introducing any additional risk to patients.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age between 18 and 80 years
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Patients scheduled for upper extremity surgery under ultrasound-guided axillary brachial plexus block as part of routine clinical practice
  • Ability to obtain adequate real-time ultrasound imaging of the axillary region prior to block performance
  • Provision of written informed consent

Exclusion Criteria

  • Inability to clearly visualize the axillary artery and at least one peripheral nerve (median, ulnar, radial, or musculocutaneous) on ultrasound imaging
  • Presence of significant ultrasound artifacts impairing image interpretation
  • History of previous surgery in the axillary region causing anatomical distortion
  • Anatomical deformities or significant anatomical variations in the axillary region
  • Inadequate ultrasound image quality due to severe obesity or other technical limitations
  • Failure to obtain real-time ultrasound imaging prior to block performance
  • Withdrawal of informed consent

Arms & Interventions

Patients Undergoing Ultrasound-Guided Axillary Brachial Plexus Block

Patients undergoing upper extremity surgery in whom ultrasound-guided axillary brachial plexus block is performed as part of routine clinical practice. Real-time ultrasound images will be evaluated simultaneously by an artificial intelligence system and experienced anesthesiologists. No additional intervention will be performed on patients.

Intervention: Ultrasound-Guided Axillary Brachial Plexus Block (Routine Clinical Practice) (Procedure)

Outcomes

Primary Outcomes

Agreement in Target Point Identification Between Artificial Intelligence and Anesthesiologists

Time Frame: During block procedure (ultrasound imaging)

Agreement between artificial intelligence (AI) and experienced anesthesiologists in identifying target injection points will be evaluated using the intraclass correlation coefficient (ICC). Target points will be defined using coordinate-based measurements on real-time ultrasound images.

Secondary Outcomes

  • Proportion of Measurements Within Clinically Acceptable Agreement(During block procedure)
  • Agreement in Nerve Identification(During block procedure)
  • Spatial Difference Between Target Points(During block procedure)

Investigators

Sponsor
Gaziantep City Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Muhammed Gökhan Abay

Specialist Physician, Department of Anesthesiology and Reanimation

Gaziantep City Hospital

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