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临床试验/NCT02883465
NCT02883465已完成不适用

Ultrasound Diagnostic for Diaphragmatic Dysfunction in Reanimation and Influence Over Mechanical Ventilation Weaning Period

Centre Hospitalier Saint Joseph Saint Luc de Lyon6 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2015年3月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
74
试验地点
6
主要终点
Extubation success rate

研究概览

简要总结

Extubation is a crucial step when patients are being weaned from mechanical ventilator support. Indeed, the patient has to face an increasing burden imposed to the ventilation system. The ability to overcome this event will determine the patient survival. A warning signal could be very useful is this situation. 2 recent studies have shown that measuring diaphragmatic cupolas and muscular fibers thickening fraction could help to spot a population with a high risk of "diaphragmatic weakness", characterized by a high failure extubation rate. This study aims to verify that this kind of group of patients does exist.

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

  • Successful spontaneous breathing trial and extubation expected on the same day and 1 of the following criteria :
  • Age > 65
  • Mechanical ventilation during > 7 days
  • Cardiac history (ischemic, rhythmic or valve cardiopathy)
  • Respiratory history (documented or likely chronic respiratory failure)

排除标准

  • Patient who is tracheotomized
  • Peripheric neuromuscular disease (myasthenia, myopathy)
  • Surgery circumstances that could affect the quality of the ultrasound exam (drains or bandages)
  • Pregnant woman
  • Age < 18

结局指标

主要结局

Extubation success rate

时间窗: 7 days after the reported extubation

Extubation success rate, defined as no reintubation 7 days after the reporting extubation

次要结局

  • Length of stay in reanimation unit (days)(At discharge of reanimation unit (up to 1 year))
  • Length of mechanical ventilation(At the extubation time)
  • Mortality(At discharge of reanimation unit (up to 1 year))
  • Number of patients with invasive or non-invasive mechanical ventilation(48 hours after the extubation)
  • Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a clinical parameter : quantity of secretions measured with a defined scale(At the extubation time)
  • Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a clinical parameter : presence/absence or cervical tonus(At the extubation time)
  • Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a paraclinical parameter : peak flow measured in L/min (liters per minute)(At the extubation time)
  • Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a paraclinical parameter : maximal inspiratory pressure in centimeters of water(At the extubation time)
  • Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a paraclinical parameter : peak flow when coughing measured in L/min (liters per minute)(At the extubation time)
  • Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a clinical parameter : cough strength measured with a defined scale(At the extubation time)
  • Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a clinical parameter : F/Vt ratio measured in breaths/min/L(At the extubation time)
  • Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a paraclinical parameter : minimal expiratory pressure measured in centimeters of water(At the extubation time)
  • Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a paraclinical parameter : P0,1 measured in milliseconds(At the extubation time)

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 (6)

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