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临床试验/NCT05108441
NCT05108441已完成不适用

Comparison of Quadriceps Femoris Measurements in Critically Ill Children, Using Bedside Ultrasound and Magnetic Resonance Imaging

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2022年2月28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
35
试验地点
1
主要终点
intraclass correlation coefficient between ultrasound measurements and magnetic resonance imaging measurements

研究概览

简要总结

A vast majority of children admitted to paediatric intensive care (PICU) present with faltering growth during their admission. Muscle mass loss is an early, intense and frequent phenomenon in this setting, which is associated with impaired outcomes. Recent international guidelines recommend monitoring both nutritional status and muscle mass throughout hospital stay. Recent studies have used quadriceps femoris (QF) measurements as a surrogate for lean mass assessment, and monitored them with bedside ultrasound (QF thickness and QF cross sectional area). However, ultrasound cross sectional area inter-operator reproducibility has not been validated so far, and none of these ultrasound measurements has been validated against their gold standard i.e. magnetic resonance imaging measurements. This validation process should be conducted to allow interpreting ultrasound muscle measurements, prior to the implementation of ultrasound measurments into clinical practice.

We hypothesise that ultrasound measurements of QF thickness and cross sectional area are reliable compared to the magnetic resonance imaging gold standard, and that QF cross sectional area has a reliable inter-operator reproducibility.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
1 Year 至 17 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •critically ill children from 0 to 17 years old
  • •magnetic resonance imaging planned for any medical reason
  • •sedated child for any medical reason
  • •absence of parental/patient refusal to participate to the study

排除标准

  • •congenital neuromuscular disease
  • •no possible access to the thigh (e.g. dressing, drains, gypsum)
  • •anatomical anomaly of the limb, that would compromise localizing thigh landmarks (patella, groin)
  • •inability to obtain limb rest and/or thigh muscle decontraction
  • •risk induced by mobilization of the patient for ultrasound or magnetic resonance imaging purpose
  • •absence of social insurance

研究组 & 干预措施

Echo

Other

Ultrasound and magnetic resonance imaging measurements of quadriceps femoris

干预措施: Ultrasound and magnetic resonance imaging measurements of quadriceps femoris (Other)

结局指标

主要结局

intraclass correlation coefficient between ultrasound measurements and magnetic resonance imaging measurements

时间窗: All ultrasound measurements will be made the same day than the magnetic resonance imaging, in a 6 hour-range prior or after the magnetic resonance imaging.

The mean of 4 measurements of quadriceps femoris thickness and the mean of 3 measurements of quadriceps femoris cross sectional area, performed by ultrasound, will be compared with the measurements means performed by magnetic resonance imaging

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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