- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07915206
Evaluation of Large Language Models in Parasternal Block Ultrasound Interpretation
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.
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Engin ihsan Turan, principal investigator
- Telefonní číslo: +9005382431114
- E-mail: enginihsan@hotmail.com
Studijní místa
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Istanbul, Turecko (Türkiye), 34303
- Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
32
Popis
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: COHORT
- Časové perspektivy: PROSPECTIVE
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
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. |
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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Correct Local Anesthetic Deposition
Časové okno: 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. |
During the ultrasound-guided block procedure
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Anatomical Identification Accuracy
Časové okno: During the ultrasound-guided block procedure
|
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. |
During the ultrasound-guided block procedure
|
|
Needle Tip Position
Časové okno: During the ultrasound-guided block procedure
|
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. |
During the ultrasound-guided block procedure
|
|
Local Anesthetic Spread
Časové okno: During the ultrasound-guided block procedure
|
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. |
During the ultrasound-guided block procedure
|
|
Procedural Risk Identification
Časové okno: During the ultrasound-guided block procedure
|
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. |
During the ultrasound-guided block procedure
|
|
Clinical Recommendation Quality
Časové okno: During the ultrasound-guided block procedure
|
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. |
During the ultrasound-guided block procedure
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Agreement With Expert Assessment
Časové okno: During the ultrasound-guided block procedure
|
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. |
During the ultrasound-guided block procedure
|
Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- LLMs success-Parasternal Block
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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