Ultrasound, Nutritional Status, and Outcomes in Surgical ICU

Ultrasound Indicators of Nutritional Status and Treatment Outcomes in Surgical Patients in the Intensive Care Unit

Ultrasound Indicators of Nutritional Status and Treatment Outcomes in Surgical Patients in the Intensive Care Unit

Study Overview

• Status: Recruiting
• Conditions: Frailty; Nutritional Status; Muscle Thickness of the Quadriceps Femoris

Detailed Description

The surgical intensive care unit (ICU) provides continuous preoperative and postoperative monitoring of hemodynamically unstable, critically or potentially critically ill patients whose treatment requirements exceed the scope of the competent surgical department. The most common reasons for admission to the ICU are older age, multiple comorbidities, sepsis, demanding and high-risk surgery, and complications during the procedure. The literature increasingly reports that patients' nutritional status and clinical frailty are predictors of ICU treatment duration and outcome. The nutritional status (NS) of patients in intensive care units (ICUs) is assessed using clinical and laboratory indicators, including body mass index (BMI), the clinical frailty score, and hemoglobin and albumin levels. It is quantified by rating scales such as NRS (Nutritional Risk Screening) and MUST (Malnutrition Universal Screening Tool).

Frailty syndrome is defined as a patient's reduced capacity to tolerate changes in physical, physiological, and cognitive body functions. Given the reduction in the organism's physiological reserves, the patient becomes vulnerable to stressors and acute complications associated with the health condition. Patient frailty is correlated with aging, and age is among the most important determinants of frailty. In the intensive care unit, patient frailty is an important predictor of the duration and outcome of treatment, the development of complications during hospitalization, and, as noted above, the consumption of available resources. Assessment of patient frailty enables the appropriate selection of therapeutic procedures and provides overall support to the patient, aiming to achieve optimal treatment outcomes. Patient frailty can be measured using clinical scales; the most commonly used are the Clinical Frailty Scale (CSF) and the modified frailty index (mFI).

Ultrasound is a diagnostic tool that, due to its non-invasiveness and ease of use, is increasingly used to assess the patient's condition and changes during treatment. The most commonly measured ultrasound indicators in intensive care are the presence of effusion or blood in body cavities, flow through blood vessels, and measurement of distance for puncture purposes.

Ultrasound has recently been used to assess the patient's nutritional status by measuring muscle thickness and echogenicity, most often of the upper leg muscles, such as the quadriceps. Muscle cross-sectional area and the thickness of the adipose tissue above it are often measured.

Studies on nutritional status and its relationship with muscle echogenicity in the surgical patient population are rare.

The prospective observational study will include consecutive patients of both genders admitted to the Department of Intensive Care of the Clinical Hospital Center in Osijek. The expected number of subjects is 50. The study will be conducted after approval by the ethics committee of the Clinical Hospital Center in Osijek, and before inclusion, the investigator will obtain informed consent from the patient or a guardian. Patients who have had surgery on their right leg, on which muscle thickness and echogenicity will be measured, patients for whom informed consent is not obtained, and patients who are paraplegic will not be included in the study.

Demographic data will be recorded from medical records and the hospital information system for each individual subject. Patient demographics (age, gender), comorbidities, laboratory parameters (hemoglobin, albumin, lactate), reason and duration of intensive care unit hospitalization, and time required to wean the patient from mechanical ventilation will be recorded. Patient frailty will be assessed during an interview. For patients who are unable to provide information, information will be collected from family members. For the purposes of this study, the CFS will be used, which categorizes patients from 1 (very active, physically strong) to 9 (very sick, not expected to survive more than 6 months). The examiner will perform an ultrasound examination of the thigh muscles (m. rectus femoris, m. vastus intermedius, m. vastus medialis, m. vastus lateralis) with a linear ultrasound probe for each subject within 48 hours of admission to the intensive care unit (ICU), measure the thickness of the muscle and the fatty tissue immediately above it, and display the dimensions in mm. Muscle echogenicity will be expressed numerically using image analysis. Signal intensity will be calculated in a standard 5 × 5 mm area, equal across all images, using the ImageJ/Fiji software. The average of 3 ultrasound measurements will be calculated. In addition to ultrasound measurements, laboratory indicators of the patient's nutritional status are also important. Hemoglobin and serum albumin are most often associated with nutritional status. Their values are usually reduced in patients with clinical frailty, and the finding of anemia and hypoproteinemia of varying degrees is common in people with limited mobility, malnutrition, or in people with specific nutritional deficiencies, e.g., in liver cirrhosis. The values will be compared computationally with clinical indicators such as patient frailty, hemoglobin, albumin and the patient's status assessment obtained by rating scales (CSF, NRS).

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Slavica Kvolik, prof.; Phone Number: 098723925; Email: skvolik@mefos.hr
• Study Contact Backup: Name: Stjepan Juric, Prof; Phone Number: +38531511511; Email: stjepan.juric@kbco.hr

Study Locations

• Croatia
  • Osijek, Croatia, 31000
    • Recruiting
    • Osijek University Hospital; Medical Faculty
    • Contact: Slavica Kvolik; Phone Number: 098723925; Email: skvolik@mefos.hr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The study population will be randomly selected patients admitted to the intensive care unit after undergoing a surgical procedure. These surgical procedures include abdominal, neurosurgical, plastic-reconstructive, traumatological, thoracic, and maxillofacial surgeries. Patients will be included regardless of age, gender, or whether the procedure was emergency or elective.

Description

Inclusion Criteria:

• postoperative intensive care

Exclusion Criteria:

• surgery of the right leg
• paraplegia, tetraplegia
• refusal of the patient/guardian to participate in the research (informed consent not signed)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Surgical patients in the intensive care unit; The prospective observational study will include consecutive patients admitted to the Department of Intensive Care of the Clinical Hospital Center in Osijek. Patients will be randomly included, regardless of age, gender, or type of surgical procedure. The study will be conducted after approval by the ethics committee of the Clinical Hospital Center in Osijek, and before inclusion, the investigator will obtain informed consent from the patient or a guardian. Patients who have had surgery on their right leg, on which muscle thickness and echogenicity will be measured, patients for whom informed consent is not obtained, and patients who are paraplegic will not be included in the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nutritional Risk Screening 2002	The Nutritional Risk Screening 2002 (NRS-2002) is a rapid, validated tool designed by the European Society for Clinical Nutrition and Metabolism (ESPEN) to identify hospitalized patients at risk of malnutrition and requiring nutritional support. It calculates a total score (0-7) based on impaired nutritional status, disease severity, and age (≥70 years).	Day 1
Vastus intermedius thickness	Vastus intermedius thickness measured by ultrasound and expressed in centimeters.	Day 1
Rectus femoris thickness	Rectus femoris thickness measured by ultrasound and expressed in centimeters.	Day 1
Vastus medialis thickness	Vastus medialis thickness measured by ultrasound and expressed in centimeters.	Day 1
Vastus lateralis thickness	Vastus lateralis thickness measured by ultrasound and expressed in centimeters.	Day 1
Rectus femoris echogenicity	Muscle echogenicity will be analyzed using ImageJ software and expressed as mean grey value.	Day 1
Vastus medialis echogenicity	Muscle echogenicity will be analyzed using ImageJ software and expressed as mean grey value.	Day 1
Vastus lateralis echogenicity	Muscle echogenicity will be analyzed using ImageJ software and expressed as the mean gray value.	Day 1
Adipose tissue thickness	Thickness of adipose tissue above quadriceps femoris muscle will be mesured by ultrasound and expressed in centimeters.	Day 1
Body mass index ˙(BMI)	Body Mass Index (BMI) is a screening tool that estimates body fat by dividing a person's weight in kilograms by the square of their height in meters (kg/m2)	Perioperative
Length of mechanical ventilation	Time from admission to the intensive care unit to the onset of spontaneous breathing. The time of admission to the intensive care unit is the start of mechanical ventilation. It lasts until extubation (removal of the endotracheal tube) and continuation of spontaneous breathing. It is expressed in hours. Whether the patient is intubated again, these two ventilation times are added together.	One month from admission to the ICU.
Clinical Frailty Scale	The Clinical Frailty Scale (CFS) is a 9-point clinician-judgment tool that assesses fitness-to-frailty (1=Very Fit, 9=Terminally Ill).	Day 1 (within 24 hours from admission to the intensive care unit)
Vastus intermedius echogenicity	Muscle echogenicity will be analyzed using ImageJ software and expressed as the mean gray value.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Haemoglobin	Haemoglobin levels (g/L) will be measured in the blood sample.	Day 1
Albumin	The albumin level (g/L) will be measured in the blood sample.	Day 1
C-reactive protein (CRP)	C-reactive protein (CRP) is a liver-produced protein that serves as a key biomarker of systemic inflammation, infection, and tissue damage. CRP (mg/L) will be measured in the blood sample.	Perioperative
Lactate	Lactate (mmol/L) is an energy source and a metabolic product produced in muscles, red blood cells, and the brain during anaerobic metabolism. It serves as a marker of tissue oxygenation, with elevated blood levels suggesting potential metabolic stress.	Day 1

Collaborators and Investigators

• Sponsor: Osijek University Hospital
• Investigators: Study Chair: Slavica Kvolik, prof., Osijek University Hospital; Medical Faculty Osijek

Publications and helpful links

General Publications

• Kalaiselvan MS, Yadav A, Kaur R, Menon A, Wasnik S. Prevalence of Frailty in ICU and its Impact on Patients' Outcomes. Indian J Crit Care Med. 2023 May;27(5):335-341. doi: 10.5005/jp-journals-10071-24456.
• Casey P, Alasmar M, McLaughlin J, Ang Y, McPhee J, Heire P, Sultan J. The current use of ultrasound to measure skeletal muscle and its ability to predict clinical outcomes: a systematic review. J Cachexia Sarcopenia Muscle. 2022 Oct;13(5):2298-2309. doi: 10.1002/jcsm.13041. Epub 2022 Jul 19.
• Xin C, Ma M, Wang Q, Li T, Sun Q, Jiang M, Du J, Li Z, Ma J. Correlation of ultrasound measurement of limb muscle thickness and echo intensity with frailty assessment in elderly patients undergoing malignancies surgery. Heliyon. 2024 Jan 3;10(1):e24017. doi: 10.1016/j.heliyon.2024.e24017. eCollection 2024 Jan 15.
• De Biasio JC, Mittel AM, Mueller AL, Ferrante LE, Kim DH, Shaefi S. Frailty in Critical Care Medicine: A Review. Anesth Analg. 2020 Jun;130(6):1462-1473. doi: 10.1213/ANE.0000000000004665.
• Bakshi N, Khurana A, Ferozi S. Nutrition Screening and Assessment among Critically Ill Patients [Internet]. Nutrition During Intensive Care. IntechOpen; 2024. https://doi.org/10.5772/intechopen.1007337
• Rohrig SAH, Lance MD, Faisal Malmstrom M. Surgical intensive care - current and future challenges? Qatar Med J. 2020 Jan 13;2019(2):3. doi: 10.5339/qmj.2019.qccc.3. eCollection 2019.
• Girgin T, Sayur V, Guler E, Uc C, Goktepe B, Ersin S, Uyar M, Sezer TO. Predictors of Mortality in Surgical Patients Admitted to a Tertiary Intensive Care Unit. J Clin Med. 2025 Sep 9;14(18):6369. doi: 10.3390/jcm14186369.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: March 9, 2026
• First Submitted That Met QC Criteria: March 12, 2026
• First Posted (Actual): March 16, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Risk Assessment; Ultrasonography; Intensive Care Units; Nutritional Status; Postoperative Care
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Frailty
• Other Study ID Numbers: R1-13343

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Yes, upon request sent to principal investigator
• IPD Sharing Time Frame: After study publication.
• IPD Sharing Access Criteria: Upon the reasonable request sent to principal investigator.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No