NCT07712198

Brief Summary

This prospective observational study aims to evaluate sarcopenia in intensive care patients with intracranial pathologies using ultrasound and to compare the predictive performance of different artificial intelligence models. Rectus femoris muscle thickness will be measured by ultrasound on ICU admission (Day 0) and Day 7. Prealbumin levels will be assessed on Days 0, 3, and 7, and the modified Nutrition Risk in Critically Ill (mNUTRIC) score will be calculated on the first day of ICU admission. Clinical, laboratory, and ultrasonographic data will be integrated into different artificial intelligence models to predict sarcopenia status on Day 7. The study aims to determine the effectiveness of artificial intelligence in the early identification of sarcopenia and to support future clinical decision-making in intensive care practice.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

July 14, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 17, 2026

Completed
Last Updated

September 24, 2026

Status Verified

August 1, 2026

Enrollment Period

6 months

First QC Date

July 14, 2026

Last Update Submit

September 21, 2026

Conditions

Keywords

SarcopeniaArtificial IntelligenceIntensive Care UnitRectus FemorisUltrasonographymNUTRICPrealbuminIntracranial Pathology

Outcome Measures

Primary Outcomes (1)

  • Accuracy of Artificial Intelligence Models in Predicting Day-7 Sarcopenia

    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

Secondary Outcomes (2)

  • Comparison of Predictive Performance Among AI Models

    7 Days

  • Agreement Between AI Predictions and Clinical Assessment

    7 Days

Study Arms (1)

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.

Other: Prospective Observational Assessment

Interventions

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.

Intracranial Pathology ICU Patients

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult intensive care unit patients aged 18-65 years admitted with intracranial pathologies, including intracerebral hemorrhage, epidural hemorrhage, subdural hemorrhage, subarachnoid hemorrhage, intracranial tumors, and ischemic stroke.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Trabzon University Faculty of Medicine, Kanuni Training and Research Hospital, Trabzon, 61080

Trabzon, Trabzon, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 40133525BACKGROUND
  • 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.

    PMID: 41080186BACKGROUND
  • 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.

    PMID: 39043882BACKGROUND

MeSH Terms

Conditions

Cerebral HemorrhageSubarachnoid HemorrhageHematoma, SubduralHematoma, Epidural, SpinalIschemic StrokeBrain NeoplasmsSarcopenia

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsIntracranial Hemorrhage, TraumaticCraniocerebral TraumaTrauma, Nervous SystemHematomaWounds and InjuriesStrokeCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsAtrophyPathological Conditions, AnatomicalSigns and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2026

First Posted

July 17, 2026

Study Start

January 1, 2026

Primary Completion

June 30, 2026

Study Completion

June 30, 2026

Last Updated

September 24, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared. The collected data will be used only for the purposes of this study and will remain confidential in accordance with institutional and ethical regulations.

Locations