跳至主要内容
临床试验/NCT02562495
NCT02562495已完成不适用

Interest of the Ultrasound to Evaluate the Quadriceps Muscle Wasting in Critical Ill Patients.

Centre Hospitalier Universitaire de Saint Etienne2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2016年1月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
2
主要终点
Concordance of the measurement of the quadriceps thickness by ultrasound and by CT scan

研究概览

简要总结

Intensive care unit acquired muscle weakness (ICUAW) is a common disease. After 7 days of mechanical ventilation, a quarter of patients develop an ICUAW responsible of a 15-20% of muscle loss. This is a serious pathology associated with high morbidity and mortality.

Clinical diagnosis of ICUAW is difficult and need a patient awoken. CT scan and Magnetic Resonance Imaging (MRI) are considered as "gold standards" to quantify and monitor changes in muscle mass. But these tools are not adapted to ICU patients.

Ultrasound (US) is an easy access tool at the bedside to assess muscle mass and does not expose the patient to additional radiation.

The objective of this study is to evaluate the correlation between US and CT scan to measure quadriceps muscle thickness of ICU patients.

详细描述

As part of the monitoring of the neurological disease, brain CT scans are frequently performed. At the same time, an acquisition sequence centered on the quadriceps will follow the brain sequences. Up to three brain CT scans coupled with a quadriceps imaging will be performed between the day of admission and on the tenth day of hospitalization. An ultrasound of the quadriceps will be performed concomitantly. The thickness of the quadriceps is measured by an independent operator on CT and ultrasound images.

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 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient over 18 years admitted to intensive care for a severe brain injury (Glasgow <8) and with a predictive duration of mechanical of at least 48hours

排除标准

  • Pregnancy,
  • Bilateral trauma of thighs,
  • Coma induced by poisoning or by a metabolic disorder,
  • Morbid obesity (BMI > 35).

研究组 & 干预措施

CT scan and Ultrasonography

Experimental

Up to three measurements (CT scan and Ultrasonography), will be made concurrently between the day of admission (D1) in intensive care unit and the tenth day ( D10 ) .

干预措施: CT Scan and ultrasonography (Device)

结局指标

主要结局

Concordance of the measurement of the quadriceps thickness by ultrasound and by CT scan

时间窗: Between the day of admission (D1) in intensive care unit and the tenth day ( D10 )

Concordance of each of the three measurements of the thickness of quadriceps realised concurrently by CT scan and Ultrasonography (composite measure)

次要结局

  • kinetic of the thickness of quadriceps(Between the day of admission (D1) in intensive care unit and the tenth day ( D10 ))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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