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Completed

NCT Number: NCT05807737

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

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.

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Key information

Conditions

Ultrasound Imaging

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gazi University School of Medicine

Çankaya, Ankara, 06500, Turkey (Türkiye)

About this study

Ultrasound-guided Regional Anesthesia (UGRA) is currently an effective method for the anesthesiologist. In this single-centered study, we aim to assess the accuracy of artificial intelligence effectiveness. All scans will be performed on an FDA-cleared general-purpose ultrasound device (GE Logiq, Wisconsin, USA) and software setup will be provided by the sponsor also having the software (Nerveblox, Smart Alfa Teknoloji San. Ve Tic. A.S., Ankara, Turkey).

The methodology of the study is that:

  • Three independent residents, in the 2nd, 3rd, and 4th years of education in the field of anesthesiology and also eligible to perform UGRA, will be recruited for using the artificial intelligence software (Nerveblox v1.0).
  • 40 (20 male and 20 female) volunteers will be recruited for the study and the volunteer's demographic information (body mass index, gender, age) will be considered and recorded.
  • The order of volunteers will be randomized between participants.
  • Considered peripheral nerve and plane blocks are:
  • Interscalene brachial plexus
  • Supraclavicular brachial plexus
  • Infraclavicular brachial plexus
  • Transversus abdominis plane
  • Each trainee will reach 100% "scan success" on the Nerveblox to record the raw and highlighted images.
  • Each trainee will scan only 1 time.

On the data analysis:

  • Evaluation of the accuracy of artificial intelligence software will be completed independently by 2 experts in the field of regional anesthesia using the grading scale (0: mislocated, 1: very poor, 2: poor, 3: good, 4: very good, 5: excellent).
  • Experts will be asked the evaluate the accuracy of Nerveblox highlighting performance when it reached 100%.
  • Demographic data averages will be presented on the result of the study.
  • Data will be analyzed by using SPSS 25.0 software at a 95% confidence level. For the measurements, the mean, standard deviation (SD), minimum, maximum, and median statistics will be provided.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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.

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

    Time frame: 1 month

    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.

Secondary outcomes

  1. Evaluation of rating results completed by experts according to demographic information

    Time frame: 1 day, after scanning and rating the all volunteers

    During the scanning, the volunteer's body mass index, gender, and age information will be collected. The accuracy of artificial intelligence software will be evaluated with the collected demographic information in order to learn the difference in accuracy.

Sponsors and collaborators

Lead sponsor

Smart Alfa Teknoloji San. ve Tic. A.S.

Industry

Collaborators

  • Gazi University

Registry information

Official study title

Assessment of Artificial Intelligence-based Anatomy Identification Software (Nerveblox) Designed for Ultrasound-guided Peripheral Nerve and Plane Block Scanning Procedures

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 11, 2023
Registry last updated
Apr 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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