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临床试验/NCT02973373
NCT02973373已完成不适用

MRI of the Chest Under High Frequency Ventilation

University of Lausanne Hospitals1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2016年11月1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
发起方
入组人数
10
试验地点
1
主要终点
Image quality assessment (soapbubble, maximum of first derivative, signal to noise, contrast to noise)

研究概览

简要总结

The purpose of the study is to evaluate the benefit on image quality of MRI of the chest performed under high frequency non-invasive ventilation. This technique indeed allows to generate an apnea duration of several minutes with acquisitions performed at full inspiration. This study will be applied on healthy subjects.

详细描述

High frequency ventilation (HF-V) has been applied by using a non-invasive interface allowing to obtain a prolonged apnea in awaken subjects. Such an application should be of interest for MRI taking into account its susceptibility to motion of the chest and the imperfect techniques of respiratory gating that are usually performed at end expiration. The purpose of this study is to assess the benefit on image quality of different sequences performed with and without the device in healthy subjects.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
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
是

入选标准

  • •Healthy subjets : normal respiratory function and no known lung disease
  • •Age >=18y

排除标准

  • •Pregnancy

研究组 & 干预措施

MRI with HF-NIV

Experimental

Intervention: Acquisition of MRI with High-Frequency non-invasive ventilation (HF-NIV)

干预措施: MRI with High-frequency non-invasive ventilation (Device)

MRI without HF-NIV

Active Comparator

Intervention: MRI without High-Frequency non-invasive ventilation (HF-NIV)

干预措施: MRI without High-frequency non-invasive ventilation (Other)

结局指标

主要结局

Image quality assessment (soapbubble, maximum of first derivative, signal to noise, contrast to noise)

时间窗: within 2 weeks after MRI acquisition

Image quality and artefacts will be evaluated and compared without and with the device. Sharpness of the interfaces between vessels and lung will be evaluated with the Soapbubble software (Etienne et al., Magn Reson Med. 2002 Oct;48(4):658-66). The interface between diaphragm and lung will be evaluated with the maximum of the first derivative (Tibiletti et al., Magn Reson Med. 2016 Mar;75(3):1324-32). Signal to noise and contrast to noise will be measured within regions of interest in the image.

次要结局

  • Heart and coronary arteries evaluation (soapbubble, signal to noise, contrast to noise)(within 2 weeks after MRI acquisition)
  • Subjective tolerance (questionnaire)(at the end of the MRI examination)
  • Synchronization of the acquisition(during the MRI examination)

研究者

发起方
University of Lausanne Hospitals
申办方类型
Other
责任方
Principal Investigator
主要研究者

Beigelman-Aubry Catherine

MD

University of Lausanne Hospitals

研究点 (1)

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