An observational study in Fraility, Nutrition Assessment and Ultrasound Evaluation, sponsored by Ankara Training and Research Hospital. Enrolling by invitation at 1 site in Turkey (Türkiye). Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-03-19.
Sponsored by Ankara Training and Research Hospital · Observational
Assessment of muscle mass in critically ill patients is critical for both improving clinical outcomes and monitoring the effectiveness of nutritional interventions. Loss of muscle mass is associated with mortality and morbidity in the elderly, including organ transplantation, trauma, and sepsis. Previous studies have assessed muscle mass using computed tomography. The use of computed tomography is costly, carries radiation risks, and requires the patient to be transported to a CT scanner. In contrast, ultrasonography is a noninvasive, rapid, and bedside method without radiation exposure. In particular, anterior thigh muscle thickness (ATMT) stands out as a reliable biomarker in the assessment of muscle mass. ATMT measurement includes the assessment of the combined depth of the vastus intermedius and rectus femoris muscles in the anterior thigh. There is no study in the literature examining the effects of anterior thigh muscle thickness measured by ultrasonography on malnutrition and frailty in intensive care patients. In this study, we aimed to investigate the effects of anterior thigh muscle thickness on frailty, malnutrition and length of stay in intensive care patients.
According to the World Health Organization, the global elderly population is rapidly increasing, and this is causing a significant increase in the number of elderly patients admitted to intensive care units (ICUs). The rate of individuals aged 60 and over, which was 12% in 2015, is estimated to reach 22% in 2050. This demographic change significantly increases the use of intensive care beds and the duration of healthcare services by frail and vulnerable elderly individuals. Malnutrition, frailty and mortality rates in patients hospitalized in intensive care units are among the main factors that directly affect patient prognosis. Malnutrition negatively affects both short- and long-term clinical outcomes by causing serious consequences such as weakening of the immune system, increased susceptibility to infections, delayed wound healing and decreased muscle mass. Frailty is characterized by the decrease in physiological reserves due to age and disease and has an important role in predicting clinical deterioration in intensive care patients.
The aim of our study was to investigate the effects of anterior thigh muscle thickness on frailty, malnutrition, and length of stay in intensive care in intensive care patients.
This study was designed as a prospective, observational study. The study will be conducted on patients admitted to the Ankara Education and Research Hospital Anesthesia intensive care unit for any reason after obtaining ethics committee approval.
1,780 studies on the registry are indexed under Critical Illness; 442 are open to participants now.
This study's planned enrollment of 80 is below the median of 140 across 814 observational studies indexed under Critical Illness.
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Over 65 years, critically ill patients, who are submitted to ICU.
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Exclusion Criteria:
Examine all patients both USG and Fraility scale
Also known as: Fraility Scale
Front Thigh Muscle Measurement
Anterior thigh muscle thickness will be measured using ultrasonography with a linear transducer operating at 5-10 MHz. Using ample gel and minimal probe compression, the measurement site will be marked at the midpoint between the anterior superior iliac spine (SIAS) and the superior pole of the patella. Total quadriceps thickness-defined as the combined thickness of the rectus femoris and vastus intermedius-will then be recorded. Thickness will be measured as milimeter. Ultrasound assessments will be performed within 24 hours of intensive care unit (ICU) admission and repeated on ICU days 3 and 7.
Time frame: Ultrasound assessments will be performed within 24 hours of intensive care unit (ICU) admission and repeated on ICU days 3 and 7.
Frailty Assessment
Frailty will be assessed using the Clinical Frailty Scale (CFS). Frailty status will be determined at the time of ICU admission by interviewing family members/caregivers to ascertain the patient's frailty level prior to the acute illness and hospitalization. Clinical Frailty Scale (CFS): 1 Very fit; 2 Well; 3 Managing well; 4 Vulnerable-independent but slowed, fatigued; 5 Mildly frail-needs help with instrumental ADLs (finances, transport, heavy housework, meds); 6 Moderately frail-needs help with all outside activities/housework; may need minimal help bathing/dressing; 7 Severely frail-dependent for personal care but clinically stable; 8 Very severely frail-dependent, near end of life; 9 Terminally ill-life expectancy \<6 months. Classification: 1-3 non-frail; 4 pre-frail; ≥5 frail
Time frame: Frailty will be ascertained at ICU admission by interviewing family/caregivers about the patient's frailty level prior to the acute illness and hospitalization.
Nutritional Status Assessment
Assessment nutritional risk in ICU patients and identify those at high risk of malnutrition, the NRS-2002, GLIM criteria, and the NUTRIC score will be used. (NRS-2002: Nutritional Risk Screening 2002; GLIM: Global Leadership Initiative on Malnutrition; NUTRIC: Nutrition Risk in the Critically Ill.)
Time frame: Will be ascertained at ICU admission by interviewing with family/caregivers
Critical Care Scoring System: APACHE II
The APACHE II (Acute Physiology and Chronic Health Evaluation II) score is a system used to assess mortality risk in ICU patients. It will be calculated from physiologic and clinical parameters obtained during the first 24 hours of ICU admission. The score is based on acute physiologic variables, age, and chronic health status, and ranges from 0 to 71.
Time frame: During the first 24 hours of ICU admission
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: between January 1st 2026 and May 1st 2026
Started May 2025 (actual). Primary completion is estimated for Dec 2026, 19 months after the start.
Of 439 non-industry observational studies under Critical Illness, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 45. This study's planned 19 months is below that.
Counting every sponsor, half of 442 studies reached it within 23 months; a quarter within 12 and three quarters within 46.
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Ankara Training and Research Hospital