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).
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.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital
Istanbul, 34303
Engin İhsan Turan, MD, +905382431114, enginihsan@hotmail.com
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:
- Identify the anatomical structures visible in this parasternal ultrasound recording.
- Based on the observed local anesthetic spread, determine whether the solution was deposited in the correct target fascial plane.
- Determine whether the local anesthetic spread is superficial or deep.
- If the observed spread is inadequate or occurs outside the target fascial plane, what corrective action would you recommend?
- Assess whether the needle tip is positioned within the appropriate fascial plane.
- Identify potential procedural risks involving adjacent structures, including the pericardium and internal mammary vessels.
- Which dermatomal levels are expected to be covered by this block?
- 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.
- Conditions
- Parasternal Block
- 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 group | Role | What they receive |
|---|---|---|
| Patients Undergoing Parasternal Intercostal Plane Blocks | Adult 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.
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)
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
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
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
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
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
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.
- First posted4 Nov 2026
- Study start2 Nov 2026 (estimated)
- Primary completion2 Apr 2027 (estimated)
- Study completion3 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parasternal BlockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Engin Ihsan Turan, Kanuni Sultan Suleyman Training and Research Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Multimodal Large Language Models in Interpreting Ultrasound Images of Parasternal Intercostal Plane Blocks: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07915206
- Acronym / sponsor ID
- LLMs success-Parasternal Block
- Conditions
- Parasternal Block
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 2 Nov 2026 (estimated)
- Primary completion
- 2 Apr 2027 (estimated)
- Study completion
- 3 Apr 2027 (estimated)
- First posted
- 4 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Identify the anatomical structures visible in this parasternal ultrasound recording.
- Based on the observed local anesthetic spread, determine whether the solution was deposited in the correct target fascial plane.
- Determine whether the local anesthetic spread is superficial or deep.
- If the observed spread is inadequate or occurs outside the target fascial plane, what corrective action would you recommend?
- Assess whether the needle tip is positioned within the appropriate fascial plane.
- Identify potential procedural risks involving adjacent structures, including the pericardium and internal mammary vessels.
- Which dermatomal levels are expected to be covered by this block?
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Undergoing Parasternal Intercostal Plane Blocks | – | Diagnostic Test: Multimodal Large Language Model-Based Ultrasound AssessmentAdult 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 32
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal Large Language Model-Based Ultrasound AssessmentAnonymized 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. | Diagnostic test | Patients Undergoing Parasternal Intercostal Plane Blocks |
Primary outcome
Correct Local Anesthetic Deposition
Time frame: During the ultrasound-guided block procedure
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.
6 secondary outcomes
Anatomical Identification Accuracy
Time frame: During the ultrasound-guided block procedure
Needle Tip Position
Time frame: During the ultrasound-guided block procedure
Local Anesthetic Spread
Time frame: During the ultrasound-guided block procedure
Procedural Risk Identification
Time frame: During the ultrasound-guided block procedure
Clinical Recommendation Quality
Time frame: During the ultrasound-guided block procedure
Agreement With Expert Assessment
Time frame: During the ultrasound-guided block procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
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.