- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: KİRAZ TEKİN GÜNAYDIN, MD
- Numero di telefono: +905369549350
- Email: kiraztekin.16@gmail.com
Luoghi di studio
-
-
-
Trabzon, Turchia (Türkiye)
- Reclutamento
- Trabzon University Faculty of Medicine, Kanuni Training and Research Hospital, Trabzon, 61080
-
Contatto:
- Recep Erin, MD
- Numero di telefono: +905304699135
- Email: erinrecep@gmail.com
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
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.
|
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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Accuracy of Artificial Intelligence Models in Predicting Day-7 Sarcopenia
Lasso di tempo: 7 Days
|
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.
|
7 Days
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Comparison of Predictive Performance Among AI Models
Lasso di tempo: 7 Days
|
Comparison of prediction accuracy among ChatGPT, Gemini, and Claude models for day-7 sarcopenia.
|
7 Days
|
|
Agreement Between AI Predictions and Clinical Assessment
Lasso di tempo: 7 Days
|
Evaluation of concordance between artificial intelligence model predictions and clinically determined sarcopenia status.
|
7 Days
|
Collaboratori e investigatori
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Manifestazioni neurologiche
- Disturbi cerebrovascolari
- Malattie del cervello
- Malattie del sistema nervoso centrale
- Malattie del sistema nervoso
- Malattie vascolari
- Malattia cardiovascolare
- Manifestazioni neuromuscolari
- Ferite e lesioni
- Processi patologici
- Neoplasie per sede
- Neoplasie
- Condizioni patologiche, anatomiche
- Emorragia
- Neoplasie del sistema nervoso
- Trauma craniocerebrale
- Trauma, sistema nervoso
- Neoplasie del sistema nervoso centrale
- Atrofia muscolare
- Atrofia
- Emorragie intracraniche
- Ictus
- Emorragia intracranica, traumatica
- Condizioni patologiche, segni e sintomi
- Segni e sintomi
- Ematoma
- Ictus ischemico
- Neoplasie cerebrali
- Sarcopenia
- Emorragia cerebrale
- Ematoma, subdurale
- Emorragia subaracnoidea
- Ematoma, epidurale, spinale
Altri numeri di identificazione dello studio
- 10496660-2026-25030
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Prospective Observational Assessment
-
Cairo UniversityNon ancora reclutamentoQualità del sonno, idoneità fisica e indice di massa corporea
-
IRCCS San RaffaeleAttivo, non reclutanteCarcinoma polmonare non a piccole cellule | Carenza di ricombinazione omologa | Inibitore PARP | EGFRItalia
-
New York State Psychiatric InstituteUniversity of Miami; Columbia University; University of Southern California; Feinstein...SospesoPartecipanti saniStati Uniti
-
Idoven 1903 S.L.Karolinska Institutet; AstraZeneca; Region Stockholm; Instituto de Investigación... e altri collaboratoriReclutamentoArresto cardiaco | Fattori di rischio cardiovascolareSpagna, Svezia
-
Guy's and St Thomas' NHS Foundation TrustPhilips HealthcareCompletato
-
Firat UniversitySconosciutoAttività fisica
-
Metropolitan University CollegeCompletatoDisturbi della deglutizioneDanimarca
-
Sun Yat-sen UniversityCompletato
-
Nationwide Children's HospitalCompletato
-
Jessa HospitalCompletatoCicatrice | Cardiochirurgia mininvasivaBelgio