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| Name | Class |
|---|---|
| Gazi University | OTHER |
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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:
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.
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:
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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of rating results completed by experts according to demographic information | 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. | 1 day, after scanning and rating the all volunteers |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Dudu Berrin Günaydın, Proffessor | Gazi University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gazi University School of Medicine | Çankaya | Ankara | 06500 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34008072 | Result | 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. |
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| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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