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Complication Following Peripheral Nerve Block (Diagnosis)NCT05718414

Artificial Intelligence for Ultrasound-Guided Peripheral Nerve and Plane Blocks

An observational study of Complication Following Peripheral Nerve Block (Diagnosis), run by Gazi University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this observational study is to test the accuracy of an artificial intelligence tool used for identifying ultrasound-guided block regions in healthy volunteer participants. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Ultrasound via artifical intelligence
Type of treatment
Medical device
How many people
40 participants
Where
1 siteTurkey (Türkiye)
Study dates
8 Feb 2023to 16 Feb 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Forty healthy volunteers (20 females, 20 males) over the age of 18 were recruited. After informing the participants about the study ultrasound procedure and scan regions, written informed consent was obtained from each volunteer. Demographic properties including age, gender, and body mass index (BMI)-were recorded. Participants were regarded to be normal weight, overweight, and obese according to BMI.

Who may be able to join

  • Volunteers over the age 18

Who cannot join

  • anatomical deformity in the selected regions
  • psychiatric or neurological diseases that would impair understanding of the consent form
  • inability to lie flat

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Gazi University

    Ankara

Other trials in Turkey (Türkiye)

About this study

Official title: Artificial Intelligence for Ultrasound-Guided Peripheral Nerve and Plane Block Procedures: Assistive Tool for Medical Image Interpretation

The goal of this observational study is to test the accuracy of an artificial intelligence tool used for identifying ultrasound-guided block regions in healthy volunteer participants. The main question aims to answer is:

  • Is the artificial intelligence tool effective for identifying selected ultrasound-guided nerve block regions and their anatomical landmarks?
Read more

Three anesthesiology trainees perform ultrasound scanning for 8 nerve block regions on participants. Peripheral nerve and plane block regions are;

  • Adductor canal block region
  • Axillary brachial plexus block region
  • ESP (erector spinae plane) block region
  • Femoral block region
  • PECS (pectoral) block region
  • Popliteal block region
  • Rectus sheath block region
  • Superficial cervical plexus block region
Read the detailed description

Sonoanotomy knowledge is essential for ultrasound-guided regional anesthesia (UGRA) procedures. We aimed to assess the accuracy of artificial intelligence (AI) software used to assist sonoanatomy interpretation by highlighting anatomical structures in peripheral nerve and plane blocks in recognizing anatomical structures.

All scans were performed with an ultrasound device (GE Logiq, Wisconsin, USA) having AI software (Nerveblox, Smart Alfa Teknoloji San. Ve Tic. A.Ş., Ankara, Turkey). Using this setup, when a user performs an ultrasound scan, the AI software provides the user with real-time feedback about the identification of anatomical structures/landmarks.

The AI software is designed to provide three major feedback signals to the user in real-time;

  • name tags for each anatomical structure
  • color overlays for each anatomical structure
  • scan success rate for the entire image

Color overlays and name tags are transparency-adjusted highlights and dots that provide the user with more general spatial feedback on the anatomical layout. The plane completeness rate is visualized with a "scan success" gauge, which guides the user in a way that shows how close the current image is to the ideal visualization of predefined landmarks.

The Peripheral nerve and plane block regions (their anatomical landmarks) that the AI software can identify are;

  • Adductor Canal Block Region (Femoral artery, Sartorius muscle, Saphenous nerve, and Vastus medialis muscle)
  • Axillary Brachial Plexus Block Region (Axillary artery, Biceps brachii muscle, Coracobrachialis muscle, Conjoint tendon, Musculocutaneous nerve, and Triceps brachii muscle)
  • ESP (Erector Spinae Plane) Block Region (Erector spinae muscle, Pleura, Rhomboid muscle, Trapezius muscle, and Transverse process)
  • Femoral Block Region (Femoral artery, Femoral vein, Femoral nerve, and Iliopsoas muscle)
  • PECS (Pectoral) Block Region (Pleura, Pectoralis minor muscle, Pectoralis major muscle, Rib, and Serratus anterior muscle
  • Popliteal Block Region (Common peroneal nerve, Popliteal artery, Popliteal vein, and Tibial nerve)
  • Rectus Sheath Block Region (Peritoneal cavity, Rectus abdominis muscle, Anterior rectus sheath, and posterior rectus sheath)
  • Superficial Cervical Plexus Block Region (Anterior scalene muscle, Carotid artery, Cervical plexus, Jugular vein, and Sternocleidomastoid muscle)

For the study, three anesthesiology trainees who were trained in regional anesthesia and qualified to perform UGRA techniques will scan each volunteer with the guidance of AI software. In total, three residents will perform scans of 8 block types for all 40 volunteers. All scan images will be saved. Using this procedure, 960 ultrasound images will be acquired in both raw and AI-processed forms for expert assessment.

An anesthesiologist with expert knowledge of ultrasound-guided regional anesthesia techniques, and a radiologist with extensive experience in ultrasound will review and score the accuracy of the AI software on the acquired ultrasound images. To obtain a more precise result, the assessment of the AI software will be performed separately for each anatomical structure of the selected block regions.

The experts are asked to evaluate and rate (0: mislocated, 1: very poor, 2: poor, 3: good, 4: very good, 5: excellent) the name tags and color overlays placed by the AI software. If a name tag (represented by a dot and abbreviation of the structure name) for an anatomical structure is located in a way that it is not within the visual boundaries of the anatomical structure, then the score will be "0: mislocated." If a name tag for an anatomical structure is correctly placed within the visual boundaries and able to represent the anatomical structure, then the score should be between "1: very poor" and "5: excellent," according to the consistency of the surrounding color overlay and the underlying anatomical structure.

Data will be analysed by using SPSS 26 software at a 95% confidence level. For the measurements, the mean, standard deviation (SD), minimum, maximum, and median statistics will be provided. Because the "score" variable is an ordinal measurement between 0 and 5 and does not provide a normal distribution in the regions, non-parametric methods will be used in the analysis.

Being tested
Ultrasound via artifical intelligence
Keywords
Ultrasound-Guided Nerve or Plane Block, Artificial Intelligence
Medical subject headings
Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ultrasound via artifical intelligenceDevice

    The peripheral nerve and plan block regions (adductor canal, axillary brachial plexus, PECS, popliteal, rectus sheath, ESP, femoral, and superficial cervical plexus regions) and related anatomical landmarks are practised by 3 anesthesiology residents who were in the training program of regional anesthesia and qualified to perform ultrasound guided techniques . Then, scans of 8 block types for all 40 volunteers; when the "scan success" gauge on the AI software was 100% at the time the images were saved. Using this procedure, 960 ultrasound images were acquired in both raw and AI-processed forms for expert assessment .

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Validation of real-time identification of anatomical landmarks associated with selected peripheral nerve and plane blocks via AI supported ultrasound practice

    In 40 healthy volunteer participants, AI supported ultrasound was used to scan each peripheral nerve and plane block to highlight the block-specific anatomical landmarks (by the three anesthesiology trainees). Then, expert practitioners score/rate the accuracy of color overlays using a 6-point scale (between 0 to 5) for a total of 4,440 anatomical landmarks by assessing raw and highlighted ultrasound images.

    Measured: After collecting and saving all scans/images performed by the anesthesiology trainees in one day, rating/scoring of all these saved raw and highlighted ultrasound scans/images by the experts in one day, single point

Secondary outcomes (1)
  1. Difference according to BMI and gender

    To evaluate whether there is a difference in score according to BMI and gender

    Measured: After saving all ultrasound scans/images in one day, rating/scoring in one day, single point,

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2023
  2. Study start8 Feb 2023
  3. Primary completion15 Feb 2023
  4. Study completion16 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05718414
Sponsor's protocol ID
E.595466
Status last verified
Feb 2023
First submitted
26 Jan 2023
Last updated
16 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 34008072
  • Bowness J, Varsou O, Turbitt L, Burkett-St Laurent D. Identifying anatomical structures on ultrasound: assistive artificial intelligence in ultrasound-guided regional anesthesia. Clin Anat. 2021 Jul;34(5):802-809. doi: 10.1002/ca.23742. Epub 2021 May 11.

    PubMed 33904628

Questions about this trial

What is this clinical trial studying?

An observational study of Complication Following Peripheral Nerve Block (Diagnosis), run by Gazi University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Validation of real-time identification of anatomical landmarks associated with selected peripheral nerve and plane blocks via AI supported ultrasound practice (time frame: After collecting and saving all scans/images performed by the anesthesiology trainees in one day, rating/scoring of all these saved raw and highlighted ultrasound scans/images by the experts in one day, single point). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05718414, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2023.

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