AzTrials
AzTrials

Parasternal BlockNCT07915206

Evaluation of Large Language Models in Parasternal Block Ultrasound Interpretation

An observational study of Parasternal Block, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This prospective observational study aims to evaluate the accuracy of multimodal large language models (LLMs) in interpreting ultrasound recordings of superficial and deep parasternal intercostal plane blocks. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Parasternal Block
What is being tested?
Multimodal Large Language Model-Based Ultrasound Assessment
Type of treatment
Injection or infusion
How many people
32 participants
Where
1 siteTurkey (Türkiye)
Study dates
2 Nov 2026to 3 Apr 2027
Phase
Observational
Are there results?
Not yet: the study is under way

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
  • No healthy volunteers
  • Adult, Older adult

Study population: 32

Who may be able to join

  • Patients aged 18-85 years.
  • American Society of Anesthesiologists (ASA) physical status I-III.
  • Undergoing elective surgery with an ultrasound-guided superficial or deep parasternal intercostal plane block.
  • Complete ultrasound video recording of local anesthetic injection.
  • Written informed consent for study participation.

Who cannot join

  • Technical failure during block performance.
  • Inadequate ultrasound recording quality preventing clear visualization of the needle tip or local anesthetic spread.
  • Missing demographic data.
  • Withdrawal of informed consent at any stage of the study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Engin ihsan Turan, principal investigator contact

+9005382431114

enginihsan@hotmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital

    Istanbul, 34303

    Engin İhsan Turan, MD, +905382431114, enginihsan@hotmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Diagnostic Accuracy of Multimodal Large Language Models in Interpreting Ultrasound Images of Parasternal Intercostal Plane Blocks: A Prospective Observational Study

This prospective observational study aims to evaluate the accuracy of multimodal large language models (LLMs) in interpreting ultrasound recordings of superficial and deep parasternal intercostal plane blocks.

Ultrasound recordings obtained during routine regional anesthesia procedures will be independently evaluated by LLMs using standardized prompts. Their ability to identify anatomical structures, assess local anesthetic spread, determine block success, and recognize potential procedural risks will be compared with expert anesthesiologist assessments.

The study aims to investigate the potential role of LLMs in ultrasound-guided regional anesthesia assessment and clinical decision support.

Read the detailed description

Study Design and Participants This prospective observational study will evaluate the diagnostic accuracy of multimodal large language models (LLMs) in interpreting ultrasound recordings of superficial and deep parasternal intercostal plane blocks (S-PIP and D-PIP).

The study will include 32 adult patients aged 18-85 years, classified as American Society of Anesthesiologists (ASA) physical status I-III, undergoing elective surgery with an ultrasound-guided parasternal intercostal plane block.

Blocks will be performed by experienced anesthesiologists as part of routine clinical practice. Ultrasound recordings will include the local anesthetic injection and its spread within the targeted fascial plane. No additional procedures will be performed for research purposes.

Ultrasound Video Acquisition Ultrasound-guided S-PIP and D-PIP procedures will be recorded in video format, including the injection process.

Videos with inadequate visualization of relevant anatomical structures, needle placement, or local anesthetic spread will be excluded.

All recordings will be anonymized before evaluation. Each eligible recording will be assigned a unique identification code.

Large Language Model Evaluation ChatGPT (OpenAI) and Gemini (Google) will be evaluated using their latest available multimodal versions at the time of assessment. Exact model names, versions, access platforms, and evaluation dates will be documented.

The same ultrasound recording will be independently submitted to both models in MP4 format, provided that direct video analysis is supported by the selected model interfaces.

An identical standardized English-language prompt will be used for every recording and both LLMs. Each recording will be evaluated in a separate conversation to minimize contextual carryover.

Models will receive no patient-identifying information, expert interpretations, or feedback regarding the correctness of their responses.

The following eight questions will be presented in the same order:

  1. Identify the anatomical structures visible in this parasternal ultrasound recording.
  2. Based on the observed local anesthetic spread, determine whether the solution was deposited in the correct target fascial plane.
  3. Determine whether the local anesthetic spread is superficial or deep.
  4. If the observed spread is inadequate or occurs outside the target fascial plane, what corrective action would you recommend?
  5. Assess whether the needle tip is positioned within the appropriate fascial plane.
  6. Identify potential procedural risks involving adjacent structures, including the pericardium and internal mammary vessels.
  7. Which dermatomal levels are expected to be covered by this block?
  8. If the observed spread is inadequate or occurs outside the target fascial plane, would you recommend an additional injection? Models will be instructed to base their assessments exclusively on the provided ultrasound recording and to explicitly indicate when the available visual information is insufficient for a reliable conclusion.

Responses will be recorded without additional prompting or correction. Response time and other predefined performance parameters will also be documented.

Expert Assessment and Blinding Two experienced anesthesiology professors will participate in the expert assessment process. The first expert (Expert A) will independently review each ultrasound recording and answer the same eight standardized questions. These assessments will serve as the expert reference. LLM-generated responses and Expert A's responses will subsequently be anonymized and randomly coded to conceal their sources.

The second expert (Expert B), blinded to response origin, will independently evaluate the anonymized responses regarding their accuracy, clinical appropriateness, and agreement with the expert reference.

Responses will be assessed using predefined scoring criteria, including content similarity and an overall quality score ranging from 0 to 10.

Outcome Assessment The primary objective is to compare the diagnostic accuracy of ChatGPT and Gemini in identifying anatomical structures and determining whether the local anesthetic solution was correctly deposited within the intended fascial plane during parasternal intercostal plane blocks.

Secondary assessments will include classification of superficial versus deep local anesthetic spread, needle tip position, procedural risk identification, appropriateness of clinical recommendations, predicted dermatomal coverage, and agreement with expert assessments. Model response time, response quality, and reported confidence will also be evaluated.

Data Protection and Clinical Safety All recordings will be de-identified before submission to the LLM platforms. Model-generated interpretations will be used solely for research purposes and will not influence clinical decision-making or patient management.

The study will be conducted in accordance with the approved research protocol and applicable ethical and data protection requirements.

Being tested
Multimodal Large Language Model-Based Ultrasound Assessment

What participants receive

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

  • Multimodal Large Language Model-Based Ultrasound AssessmentDiagnostic test

    Anonymized ultrasound recordings of parasternal intercostal plane blocks will be independently evaluated using the latest available multimodal versions of ChatGPT and Gemini. Both models will receive the same MP4 recordings and identical standardized prompts to assess anatomical structures, correct deposition of local anesthetic solution within the target fascial plane, injection spread, and potential procedural risks. Responses will be compared with expert anesthesiologist assessments. No AI-generated recommendations will influence patient care.

Study groups in NCT07915206
Study groupRoleWhat they receive
Patients Undergoing Parasternal Intercostal Plane BlocksAdult patients undergoing ultrasound-guided superficial or deep parasternal intercostal plane blocks as part of routine clinical care. Anonymized ultrasound recordings of local anesthetic injection will be independently evaluated by ChatGPT and Gemini using identical standardized prompts. Model assessments will be compared with expert anesthesiologist evaluations.
Receives: Diagnostic Test: Multimodal Large Language Model-Based Ultrasound Assessment

What is being measured

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

  1. Correct Local Anesthetic Deposition

    The accuracy of ChatGPT and Gemini in determining whether the local anesthetic solution was deposited within the intended fascial plane will be evaluated using ultrasound recordings. Model assessments will be compared with the expert reference assessment. Accuracy will be calculated as the percentage of correctly classified recordings.

    Measured: During the ultrasound-guided block procedure

Secondary outcomes (6)
  1. Anatomical Identification Accuracy

    The ability of ChatGPT and Gemini to correctly identify anatomical structures visible in parasternal intercostal plane block ultrasound recordings will be evaluated against expert anesthesiologist assessments. Anatomical identification performance will be scored using predefined criteria.

    Measured: During the ultrasound-guided block procedure

  2. Needle Tip Position

    The accuracy of ChatGPT and Gemini in determining whether the needle tip is located within the intended fascial plane will be compared with the expert reference assessment. Results will be reported as the percentage of correctly classified recordings.

    Measured: During the ultrasound-guided block procedure

  3. Local Anesthetic Spread

    The ability of each model to classify local anesthetic spread as superficial or deep and identify the observed spread pattern will be compared with expert assessments. Classification accuracy will be reported as a percentage.

    Measured: During the ultrasound-guided block procedure

  4. Procedural Risk Identification

    The ability of each model to identify potential procedural risks involving adjacent anatomical structures, including the internal mammary vessels and pericardium, will be evaluated against expert assessments. Accuracy will be reported as the percentage of correctly classified recordings.

    Measured: During the ultrasound-guided block procedure

  5. Clinical Recommendation Quality

    The appropriateness of recommendations regarding inadequate local anesthetic spread, corrective actions, and additional injection will be assessed by an independent expert anesthesiologist using a predefined scoring system ranging from 0 to 10, with higher scores indicating greater clinical appropriateness.

    Measured: During the ultrasound-guided block procedure

  6. Agreement With Expert Assessment

    Agreement between ChatGPT, Gemini, and expert anesthesiologist assessments will be evaluated for predefined ultrasound interpretation parameters. Agreement will be quantified using Cohen's kappa for applicable categorical assessments.

    Measured: During the ultrasound-guided block procedure

Timeline

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

  1. First posted4 Nov 2026
  2. Study start2 Nov 2026 (estimated)
  3. Primary completion2 Apr 2027 (estimated)
  4. Study completion3 Apr 2027 (estimated)

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
Cohort
Time perspective
Prospective
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07915206
Sponsor's protocol ID
LLMs success-Parasternal Block
Status last verified
Nov 2026
First submitted
29 Oct 2026
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Parasternal Block, run by Kanuni Sultan Suleyman Training and Research Hospital 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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 6 Nov 2026. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Engin ihsan Turan, principal investigator (+9005382431114, enginihsan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correct Local Anesthetic Deposition (time frame: During the ultrasound-guided block procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 6 Nov 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in