- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Engin ihsan Turan, principal investigator
- Número de teléfono: +9005382431114
- Correo electrónico: enginihsan@hotmail.com
Ubicaciones de estudio
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Istanbul, Turquía (Türkiye), 34303
- Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
32
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Correct Local Anesthetic Deposition
Periodo de tiempo: During the ultrasound-guided block procedure
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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
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Anatomical Identification Accuracy
Periodo de tiempo: During the ultrasound-guided block procedure
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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
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Needle Tip Position
Periodo de tiempo: During the ultrasound-guided block procedure
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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
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Local Anesthetic Spread
Periodo de tiempo: During the ultrasound-guided block procedure
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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
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Procedural Risk Identification
Periodo de tiempo: During the ultrasound-guided block procedure
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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
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Clinical Recommendation Quality
Periodo de tiempo: During the ultrasound-guided block procedure
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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
Periodo de tiempo: During the ultrasound-guided block procedure
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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
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Colaboradores e Investigadores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- LLMs success-Parasternal Block
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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