Validation of Bedside Ultrasound to Predict Body Composition in Non- and Critically Ill Patients: The USVALID Prospective Study
试验速览
- 阶段
- 不适用
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- prediction (r2) of CT-based whole body fat volume from ultrasound-based fat thickness
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •patients younger than 18 years
研究组 & 干预措施
Body Composition Measurements
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.
干预措施: Body Composition Measurements (Other)
结局指标
主要结局
prediction (r2) of CT-based whole body fat volume from ultrasound-based fat thickness
时间窗: Ultrasound measurement once-only within 48 hours after the CT scan
In a linear regression model, the dependent variable is CT-based whole body fat volume. The independent variable is ultrasound-based fat thickness. The prediction (r2) of CT-based fat volume in the multiple linear regression model is the outcome.
prediction (r2) of CT-based whole body muscle volume from ultrasound-based muscle thickness
时间窗: Ultrasound measurement once-only within 48 hours after the CT scan
In a linear regression model, the dependent variable is CT-based whole body muscle volume. The independent variable is ultrasound-based muscle thickness. The prediction (r2) of CT-based muscle volume in the multiple linear regression model is the outcome.
次要结局
- interrater reliability (bias in Bland Altman analysis) of ultrasound muscle/fat thickness(repeated US measurement in 60 patients once-only within 48 hours after the CT scan)
- prediction (r2) of BIA-based whole body fat volume from ultrasound-based fat thickness(BIA measurement once-only within 48 hours after the CT scan)
- prediction (r2) of BIA-based whole body muscle volume from ultrasound-based muscle thickness(BIA measurement once-only within 48 hours after the CT scan)
- intrarater reliability (bias in Bland Altman analysis) of ultrasound muscle/fat thickness(repeated US measurement in 60 patients once-only within 48 hours after the CT scan)
- muscle strength in patients with different CT-based body compositions (sarcopenia, malnutrition, obesity, sarcopenic obesity)(muscle strength measurement once-only within 48 hours after the CT scan)
研究者
Arabella Fischer, MD
Dr.
Medical University of Vienna