VALIDation of Bedside Ultrasound of Muscle Layer Thickness of the Quadriceps in the Critically Ill Patient: The VALIDUM Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 204
- 主要终点
- Validity of bedside US of QMLT
研究概览
简要总结
The overall objective is to evaluate the validity of bedside US of QMLT and MF-BIA by comparing measurements from US and MF-BIA to those estimates of lean body mass obtained from CT Scan of abdomen when done for clinical reasons.
The investigators expect to observe a high degree of correlation between these 3 baseline measures and the changes in US measures and MF-BIA over time to correlate with changes to CT Scan measures of lean body mass.
详细描述
The overall objective is to evaluate the validity of bedside US of QMLT and MF-BIA by comparing measurements from US and MF-BIA to those estimates of lean body mass obtained from CT Scan of abdomen when done for clinical reasons.
The investigators expect to observe a high degree of correlation between these 3 baseline measures and the changes in US measures and MF-BIA over time to correlate with changes to CT Scan measures of lean body mass.
This is a multi center, prospective, observation study across 5-6 intensive care units which will enroll 200 participants over a 12 month enrollment period followed by a 6 month period to complete data analysis.
This study will enroll a broad heterogeneous participant population who will be admitted to the ICU for inpatient care. We are particularly interested in the cohort of participant with trauma but will enroll non-trauma participants who have CT scans as well to do some between group comparisons. Participants enrolled to this study will be followed until they are discharged from the index hospital.
This is a prospective, observational study therefore no specific interventions will be associated with this study. The following information will be collected and recorded during ICU and hospital stay:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Abdominal CT scan performed for clinical reasons within 24 hours before or 72 hours after admission
排除标准
- •Patients under age 18 years
- •Moribund patient with devastating injuries and not expected to survive
- •Patients whose clinical condition precludes performing an ultrasound
- •Pregnant women
- •Prisoners
- •Mentally-disabled individuals
结局指标
主要结局
Validity of bedside US of QMLT
时间窗: 12 months
To evaluate the validity and reliability of bedside US by comparing measurements from US and to those estimates of lean body mass obtained from CT Scan of abdomen.
次要结局
未报告次要终点
研究者
Daren K. Heyland
Director of Clinical Evaluation Research Unit
Queen's University
