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临床试验/NCT04676464
NCT04676464已完成不适用

VALIDation of Bedside Ultrasound of Muscle Layer Thickness of the Quadriceps in the Critically Ill Patient: The VALIDUM Study

Clinical Evaluation Research Unit at Kingston General Hospital0 个研究点目标入组 204 人开始时间: 2013年12月最近更新:
适应症

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

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

发起方
Clinical Evaluation Research Unit at Kingston General Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Daren K. Heyland

Director of Clinical Evaluation Research Unit

Queen's University

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