- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07712198
Al Prediction of Sarcopenia Risk in Neurocritical ICU Patients
Artificial Intelligence-Based Prediction of Sarcopenia Risk in Intensive Care Unit Patients With Intracranial Pathology
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
This study is designed as a prospective observational study. Patients admitted to the Level III Intensive Care Units of Trabzon University Faculty of Medicine, Kanuni Training and Research Hospital, Kaşüstü Campus, due to intracranial pathologies between January 1, 2026, and June 30, 2026, will be included. Approximately 100-150 patients are planned to be evaluated.
Demographic data of the enrolled patients will be recorded, and the modified Nutrition Risk in Critically Ill (mNUTRIC) score will be calculated on the first day of intensive care unit admission. Rectus femoris muscle thickness will be evaluated by ultrasonography on Day 0 and Day 7 of ICU admission. All ultrasonographic measurements will be performed using the same ultrasound device and by the same investigator according to a standardized protocol. During the measurements, the patient will be positioned supine, the knee will be kept in extension, and the muscle will be evaluated in a relaxed position. Three repeated measurements will be obtained at each assessment, and the mean value will be recorded.
As part of the laboratory assessment, prealbumin levels will be measured on Days 0, 3, and 7. Biochemical parameters evaluated during routine clinical follow-up will be recorded from the hospital information system.
No intervention, additional procedure, or treatment modification will be performed as part of this study. All data will consist of observational data obtained during routine clinical follow-up. Data collection will be conducted by a resident physician from the Department of Anesthesiology and Reanimation with experience in intensive care.
The collected clinical, laboratory, and ultrasonographic data will be provided to different artificial intelligence models, and their accuracy and performance in predicting sarcopenia development on Day 7 will be evaluated. The primary objective of the study is to assess the predictive performance of artificial intelligence models, including ChatGPT, Gemini, and Claude, for Day 7 sarcopenia development in intensive care patients with intracranial pathologies. Secondary objectives include comparing artificial intelligence predictions with clinical assessments, comparing predictive performance among different artificial intelligence models, and evaluating the potential usability of artificial intelligence models as clinical decision-support tools in intensive care practice.
All data will be de-identified before analysis, and patient confidentiality will be maintained. Study data will be stored in a secure digital environment accessible only to the research team.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: KİRAZ TEKİN GÜNAYDIN, MD
- Número de teléfono: +905369549350
- Correo electrónico: kiraztekin.16@gmail.com
Ubicaciones de estudio
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Trabzon, Turquía (Türkiye)
- Reclutamiento
- Trabzon University Faculty of Medicine, Kanuni Training and Research Hospital, Trabzon, 61080
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Contacto:
- Recep Erin, MD
- Número de teléfono: +905304699135
- Correo electrónico: erinrecep@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Age between 18 and 65 years
- Admission to the intensive care unit due to intracranial pathology (intracerebral hemorrhage, epidural hemorrhage, subdural hemorrhage, subarachnoid hemorrhage, intracranial tumors, or ischemic stroke)
- Informed consent obtained from the patient or legally authorized representative
Exclusion Criteria:
- Age <18 years or >65 years
- Failure to achieve nutritional targets according to ESPEN guidelines
- Palliative care or home care patients
- Morbid obesity (BMI ≥40 kg/m²)
- History of neuromuscular disease
- Lower extremity amputation
- History of trauma affecting the thigh region
- Pregnancy
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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Intracranial Pathology ICU Patients
Adult patients admitted to the intensive care unit with intracranial pathologies, including intracerebral hemorrhage, subarachnoid hemorrhage, subdural hematoma, epidural hematoma, intracranial tumors, and ischemic stroke.
Participants will be prospectively observed.
Rectus femoris muscle thickness will be measured by ultrasonography on days 0 and 7, and prealbumin levels will be assessed on days 0, 3, and 7.
No experimental intervention or treatment modification will be performed.
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Prospective observational assessment including rectus femoris ultrasonography, prealbumin measurements, mNUTRIC scoring, and collection of routine clinical data.
No experimental intervention or treatment modification will be performed.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Accuracy of Artificial Intelligence Models in Predicting Day-7 Sarcopenia
Periodo de tiempo: 7 Days
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Evaluation of the predictive performance of ChatGPT, Gemini, and Claude models for day-7 sarcopenia in ICU patients with intracranial pathology using rectus femoris muscle thickness, prealbumin levels, and clinical data.
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7 Days
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Comparison of Predictive Performance Among AI Models
Periodo de tiempo: 7 Days
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Comparison of prediction accuracy among ChatGPT, Gemini, and Claude models for day-7 sarcopenia.
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7 Days
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Agreement Between AI Predictions and Clinical Assessment
Periodo de tiempo: 7 Days
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Evaluation of concordance between artificial intelligence model predictions and clinically determined sarcopenia status.
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7 Days
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Phongpreecha T, Ghanem M, Reiss JD, Oskotsky TT, Mataraso SJ, De Francesco D, Reincke SM, Espinosa C, Chung P, Ng T, Costello JM, Sequoia JA, Razdan S, Xie F, Berson E, Kim Y, Seong D, Szeto MY, Myers F, Gu H, Feister J, Verscaj CP, Rose LA, Sin LWY, Oskotsky B, Roger J, Shu CH, Shome S, Yang LK, Tan Y, Levitte S, Wong RJ, Gaudilliere B, Angst MS, Montine TJ, Kerner JA, Keller RL, Shaw GM, Sylvester KG, Fuerch J, Chock V, Gaskari S, Stevenson DK, Sirota M, Prince LS, Aghaeepour N. AI-guided precision parenteral nutrition for neonatal intensive care units. Nat Med. 2025 Jun;31(6):1882-1894. doi: 10.1038/s41591-025-03601-1. Epub 2025 Mar 25.
- Lopez-Gomez JJ, Sanchez-Lite I, Fernandez-Velasco P, Izaola-Jauregui O, Cebria A, Perez-Lopez P, Gonzalez-Gutierrez J, Estevez-Asensio L, Primo-Martin D, Gomez-Hoyos E, Jorge-Godoy E, De Luis-Roman DA. Artificial intelligence-assisted rectus femoris ultrasound vs. L3 computed tomography for sarcopenia assessment in oncology patients: establishing diagnostic cut-offs for muscle mass and quality. Front Nutr. 2025 Sep 25;12:1678989. doi: 10.3389/fnut.2025.1678989. eCollection 2025.
- Choi YH, Kim DH, Jeon ET, Lee HJ, Park TY, Yoon SH, Jin KN, Lee HW. Cluster analysis of thoracic muscle mass using artificial intelligence in severe pneumonia. Sci Rep. 2024 Jul 23;14(1):16912. doi: 10.1038/s41598-024-67625-2.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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
Palabras clave
Términos MeSH relevantes adicionales
- Manifestaciones neurológicas
- Trastornos cerebrovasculares
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Manifestaciones Neuromusculares
- Heridas y Lesiones
- Procesos Patológicos
- Neoplasias por sitio
- Neoplasias
- Condiciones Patológicas, Anatómicas
- Hemorragia
- Neoplasias del Sistema Nervioso
- Trauma craneoencefálico
- Trauma, Sistema Nervioso
- Neoplasias del Sistema Nervioso Central
- Atrofia Muscular
- Atrofia
- Hemorragias intracraneales
- Carrera
- Hemorragia Intracraneal Traumática
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Hematoma
- Accidente cerebrovascular isquémico
- Neoplasias Cerebrales
- Sarcopenia
- Hemorragia cerebral
- Hematoma Subdural
- Hemorragia subaracnoidea
- Hematoma Epidural Espinal
Otros números de identificación del estudio
- 10496660-2026-25030
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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