- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07532278
Agreement Between Artificial Intelligence and Anesthesiologists in Ultrasound-Guided Axillary Brachial Plexus Block
Evaluation of Agreement Between Artificial Intelligence and Experienced Anesthesiologists in Target Point Identification for Ultrasound-Guided Axillary Brachial Plexus Block: A Prospective Observational Study
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.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Muhammed Gökhan Abay
- Phone Number: +905379479745
- Email: abay.25@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
During block procedure (ultrasound imaging)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of Measurements Within Clinically Acceptable Agreement
Time Frame: During block procedure
|
The proportion of target point measurements with a difference of ≤5 mm between AI and anesthesiologists will be calculated.
A difference of ≤5 mm will be considered clinically acceptable agreement.
|
During block procedure
|
|
Agreement in Nerve Identification
Time Frame: During block procedure
|
Agreement between AI and anesthesiologists in identifying peripheral nerves (median, ulnar, radial, and musculocutaneous) will be evaluated using Cohen's kappa coefficient.
|
During block procedure
|
|
Spatial Difference Between Target Points
Time Frame: During block procedure
|
The absolute distance (in millimeters) between AI-generated and anesthesiologist-defined target points will be calculated for each measurement.
|
During block procedure
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 121
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ultrasound-Guided Nerve Block and Artificial Intelligence
-
Shanghai Jiao Tong University Affiliated Sixth...CompletedAI (Artificial Intelligence) | Ultrasound-Guided Nerve BlocksChina
-
University of IowaCompletedEfficacy of Ultrasound Guided Nerve Block
-
Huazhong University of Science and TechnologyNot yet recruitingArthroscopic Shoulder Surgery | Suprascapular Nerve Block | Bupivacaine | Ultrasound Guided Nerve Block | Axillary Nerve Block
-
Lebanese American UniversityRecruitingImpedance | Axillary Nerve Block | Popliteal Sciatic Nerve Block | Interscalene Nerve Block | Ultrasound-Guided Nerve BlocksLebanon
-
University of California, San FranciscoCompletedShoulder Arthroscopy | Ultrasound-guided Interscalene Nerve BlockUnited States
-
Tanta UniversityUnknownConventional Caudal Block | Ultrasound Guided Caudal Block | Ultrasound Guided Erector Spinae Block | Pediatric Hip SurgeryEgypt
-
Konya City HospitalBetül AfşarWithdrawnUltrasound Therapy; Complications | Nerve Block | Artificial IntelligentTurkey
-
Tunis UniversityCompletedPost Operative Analgesia | Peripheral Nerve Block | Ultrasound-guided Regional AnesthesiaTunisia
-
Tanta UniversityNot yet recruitingAnalgesia | Ultrasound Guided Block | Pediatric Surgery
-
Cairo UniversityAbdelhamid, Bassant Mohamed, M.D.; Mohamed, Ahmed A., M.D.; Hala Mostafa Gomaa; Mohamed saeid AliCompletedUltrasound Guided L1,L2 Paravertebral BlockEgypt
Clinical Trials on Ultrasound-Guided Axillary Brachial Plexus Block (Routine Clinical Practice)
-
Sohag UniversityNot yet recruiting
-
Zagazig UniversityEnrolling by invitationAchievement of High-quality Analgesia in Elbow SurgeriesEgypt
-
Merian Iselin KlinikBethesda KrankenhausCompletedShoulder Dislocation | Joint DislocationSwitzerland
-
Diskapi Yildirim Beyazit Education and Research...CompletedBrachial Plexus BlockTurkey
-
Olfa kaabachi, MDCompleted
-
Assam Medical CollegeCompleted
-
Huazhong University of Science and TechnologyCompletedMinimum Effective Concentration of Local AnestheticChina
-
Lawson Health Research InstituteCompletedObesity | Morbid ObesityCanada
-
Chinese University of Hong KongCompletedMusculoskeletal Diseases or ConditionsHong Kong
-
Federal University of São PauloUnknown