A Study to Assess the Accuracy of Artificial Intelligence for Ultrasound-guided Regional Anesthesia

NCT05807737 | Completed

• 1 other identifier: SMARTALPHA-NERVEBLOX-1021
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to assess the accuracy of Artificial Intelligence (AI) software to assist ultrasound scanning prior to peripheral nerve blocks. 40 healthy volunteers are going to be accepted to this study in which ultrasound scanning will be performed for four different block types. The main questions it aims to answer are:

• Can Nerveblox, the artificial intelligence software highlight and find the key anatomical landmarks on the provided nerve or plane block correctly?
• Can the user obtain a correct view of provided nerve or plane block, when the AI software scan success reaches 100%? Participants will be evaluated under four nerve block regions to identify their key anatomical landmarks using ultrasound-guided artificial intelligence software. Three residents with different levels of Ultrasound-guided Regional Anesthesia(UGRA) experience but eligible to perform UGRA techniques will collect the ultrasound images when the artificial intelligence software scan success fed by ultrasound reached 100%. After collecting US images, each pair of US images(highlighted and raw ) will be evaluated by 2 experts for the accuracy of AI assistance, independently and blindly.

Conditions

Ultrasound Imaging

Keywords

Ultrasound; Artificial Intelligence; Regional Anesthesia

Outcome Measures

Primary Outcomes (1)

• Accuracy of AI to identify key anatomical landmarks on real-time ultrasound image prior to ultrasound-guided peripheral nerve and plane blocks

  Residents will scan the 40 volunteers (20 male and 20 female) using the artificial intelligence software until obtaining 100% scan success which means all region-related key anatomical landmarks are identified and color-overlayed correctly. The accuracy of key anatomical landmarks will be evaluated by 2 independent experts in the field of regional anesthesia.

  1 month

Secondary Outcomes (1)

• Evaluation of rating results completed by experts according to demographic information

  1 day, after scanning and rating the all volunteers

Interventions

Ultrasound scanning with artificial intelligence DEVICE

Three residents who are eligible to perform ultrasound-guided regional anesthesia will scan volunteers in random order with artificial intelligence software (Nerveblox) fed by an FDA-cleared ultrasound device.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

In total, 20 female and 20 male healthy volunteers participated to study by accepting an informed consent form. Volunteers' body mass index, age, and gender information have been recorded. Sponsor, Smart Alfa Teknoloji San. ve Tic. A.S. paid the volunteer's logistic expenses during the study. Residents who participated in the study must be in the 2nd, 3rd, and 4th years of education scanned ultrasound images, and also have the knowledge to perform UGRA. 2 experts, who have strong knowledge and 15 years of experience least in regional anesthesia, will participate for rating the collected scans.

You may qualify if:

• Volunteers over the age of 18
• Able to accept and sign the Informed Consent Form before participating in the study

You may not qualify if:

• Volunteers below the age of 18
• Unwilling to accept or having psychiatric/neurological diseases to sign an Informed Consent Form before participating in the study
• Inability to lie flat
• Anatomical deformity in the selected regions

Sponsors & Collaborators

• Smart Alfa Teknoloji San. ve Tic. A.S.: lead
• Gazi University: collaborator

Study Sites (1)

Gazi University School of Medicine

Çankaya, Ankara, 06500, Turkey (Türkiye)

Location

Related Publications (1)

• Gungor I, Gunaydin B, Oktar SO, M Buyukgebiz B, Bagcaz S, Ozdemir MG, Inan G. A real-time anatomy identification via tool based on artificial intelligence for ultrasound-guided peripheral nerve block procedures: an accuracy study. J Anesth. 2021 Aug;35(4):591-594. doi: 10.1007/s00540-021-02947-3. Epub 2021 May 19.

  PMID: 34008072 RESULT

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Dudu Berrin Günaydın, Proffessor

  Gazi University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: April 11, 2023
• Study Start: October 15, 2020
• Primary Completion: November 15, 2020
• Study Completion: November 15, 2020
• Last Updated: April 11, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)