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临床试验/NCT03114384
NCT03114384Unknown不适用

Patient-ventilator Asynchrony During Noninvasive Ventilation Assessed Using Diaphragm Ultrasonography

Centre Hospitalier Saint Joseph Saint Luc de Lyon2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2017年4月14日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
15
试验地点
2
主要终点
Asynchronies detection with diaphragm ultrasonography

研究概览

简要总结

Fifteen healthy subjects under non-invasive ventilation will be have a recording of surface electromyogram, measurements of airway flows and pressures as well as a continuous ultrasound. The provocation of leaks on the Ventilation circuit and expiratory trigger modulation will generate a number of asynchronies between the subject and the respirator.

These records will help to assess the agreement between the detection of asynchronies using electromyography of the respiratory muscles (technique of reference) and the diaphragmatic echography. We will also compare the respective performance of two techniques of diaphragmatic exploration (excursion and thickening of the diaphragm). A sensitivity of Ultrasound technique of at least 90% will be interpreted as a satisfactory index of concordance.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy volunteer (male or female)
  • Free and Informed Consent

排除标准

  • Known pregnancy, parturient or nursing mother
  • Minor under 18 years of age
  • Major incapable
  • Non-affiliation to the social security scheme
  • Any history of respiratory pathology

结局指标

主要结局

Asynchronies detection with diaphragm ultrasonography

时间窗: thirty minutes

Evaluation of the agreement between asynchronous subject-ventilator detection using diaphragm ultrasonography and detecting the same events in using the electromyogram of the respiratory muscles (as a reference technique.

次要结局

未报告次要终点

研究者

发起方
Centre Hospitalier Saint Joseph Saint Luc de Lyon
申办方类型
Other
责任方
Sponsor

研究点 (2)

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