NCT07532278

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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
2mo left

Started Apr 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress27%
Apr 2026Jul 2026

First Submitted

Initial submission to the registry

April 9, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 15, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

April 15, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2026

Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

3 months

First QC Date

April 9, 2026

Last Update Submit

April 9, 2026

Conditions

Keywords

Ultrasound-Guided Regional AnesthesiaAxillary Brachial Plexus BlockArtificial IntelligenceUltrasound ImagingAnatomical Structure RecognitionAgreement Analysis

Outcome Measures

Primary Outcomes (1)

  • Agreement in Target Point Identification Between Artificial Intelligence and Anesthesiologists

    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.

    During block procedure (ultrasound imaging)

Secondary Outcomes (3)

  • 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

Study Arms (1)

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.

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

Interventions

Ultrasound-guided axillary brachial plexus block performed as part of routine clinical care. No additional intervention is introduced for the purposes of the study. Real-time ultrasound images obtained during the procedure will be analyzed by an artificial intelligence system and experienced anesthesiologists.

Patients Undergoing Ultrasound-Guided Axillary Brachial Plexus Block

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients aged 18-80 years with American Society of Anesthesiologists (ASA) physical status I-III undergoing upper extremity surgery under ultrasound-guided axillary brachial plexus block in routine clinical practice. Only patients with adequate real-time ultrasound imaging of the axillary region allowing identification of relevant anatomical structures will be included.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Muhammed Gökhan Abay

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist Physician, Department of Anesthesiology and Reanimation

Study Record Dates

First Submitted

April 9, 2026

First Posted

April 15, 2026

Study Start

April 15, 2026

Primary Completion (Estimated)

July 15, 2026

Study Completion (Estimated)

July 15, 2026

Last Updated

April 15, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to institutional policies and lack of infrastructure for data sharing.