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临床试验/NCT07532278
NCT07532278尚未招募不适用

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 个研究点目标入组 100 人开始时间: 2026年4月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
主要终点
Agreement in Target Point Identification Between Artificial Intelligence and Anesthesiologists

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

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

结局指标

主要结局

Agreement in Target Point Identification Between Artificial Intelligence and Anesthesiologists

时间窗: 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.

次要结局

  • 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)

研究者

发起方
Gaziantep City Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Muhammed Gökhan Abay

Specialist Physician, Department of Anesthesiology and Reanimation

Gaziantep City Hospital

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