Validation of Bedside Ultrasound to Predict Body Composition in Non- and Critically Ill Patients (USVALID)

Medical University of Vienna

Status: Unknown

Conditions: Body Composition; Ultrasound

Treatments: Other: Body Composition Measurements

Study type: Interventional

Funder types: Other

Identifiers

NCT03160222

1848/2016

Details and patient eligibility

About

The prospective study will include 200 patients and 50 critically ill patients, who had an abdominal computed tomography (CT) scan including the L3 level for any clinical reason. Ultrasound scans of the anterior thighs and forearms will be taken after the CT scan within 48 hours. Bioelectrical impedance analysis (BIA) will also be performed. In addition muscle strength, mobility, physical function and nutrition will be assessed. Primary outcome is the prediction of CT-based whole body muscle and fat volume and BIA-based fat and lean body mass from ultrasound-based muscle and fat thickness. Other secondary outcomes include the intra- and interrater reliability of the CT evaluation and ultrasound examination of muscle and fat mass. The relationship between clinical aspects (strength, mobility, physical function, nutrition) and whole body composition is another secondary outcome.

Enrollment: 250 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• cross-sectional abdominal CT scan including the level of L3 vertebra for any clinical reason
• study-related ultrasound examination must take place within 48 hours of CT

Exclusion criteria

• patients younger than 18 years

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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250 participants in 1 patient group

Body Composition Measurements

Other group

Description:

Body composition measurements comprise the ultrasound measurement of fat and muscle thickness of both upper arms and thighs, the bioelectrical impedance analysis (BIA), measurement of weight, handgrip strength, overall muscle strength (Medical Research Council scale) and questionnaires about physical activity, nutrition and fluid status.

Treatment:

Other: Body Composition Measurements