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临床试验/NCT02766946
NCT02766946已完成不适用

Ultrasound Observation of Diaphragmatic Atrophy Related to Mechanical Ventilation A Prospective Monocentric Study in Intensive Care Unit

Centre Hospitalier Saint Joseph Saint Luc de Lyon0 个研究点目标入组 97 人开始时间: 2013年6月24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
97
主要终点
Change from day 1 diaphragm thickness at day 3 and day 5

研究概览

简要总结

Ventilatory support during critical phase result in inactivity of respiratory muscles especially diaphragm muscle. These inactivity also result in change of contractile capability and quick muscular atrophy.

The aim of the study is to visualize the evolution of diaphragm thickness by echography during Mechanical Ventilation for patients with septic shock or acute respiratory distress syndrome and to compare with the evolution for patients under non-invasive ventilation and those with spontaneous ventilation. Measurements will be performed at day 1, day 5 and day 10 (if patient still under a mode of ventilation or in the unit).

The evolution of diaphragm thickness will also be compared to pectoralis muscle atrophy, which is not involved in ventilation, in order to assess respective effect of ventilatory inactivity and undernutrition linked to intensive care.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
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

  • Age ≥18 years old
  • Group 1 : under Mechanical Ventilation (time of Mechanical Ventilation for at least 5 days)
  • Group 2 : under Non-invasive Ventilation
  • Group 3 : Spontaneous Ventilation
  • Non opposition of patient (Groups 2 and 3) or non-opposition of patient family member (Group 1)

排除标准

  • Known diaphragmatic paralysis
  • Neurologic pathology with motor deficit
  • Pregnancy or breast-feeding woman

结局指标

主要结局

Change from day 1 diaphragm thickness at day 3 and day 5

时间窗: 1 day, 3 days and 5 days after introduction of Mechanical Ventilation

Diaphragm thickness measured by ultrasound

次要结局

  • Diaphragm thickness measured by ultrasound(10 days after introduction of Mechanical Ventilation)
  • Type of ventilatory support(10 days after start of ventilatory support)
  • Ventilatory mode(10 days after start of ventilatory support)
  • Diaphragmatic strength(intraoperative)
  • MRC score (Medical Research Council)(intraoperative)
  • Respiratory rate(10 days after start of ventilatory support)
  • Highest inspiratory pressure level(10 days after start of ventilatory support)
  • Pectoralis muscle thickness measured by ultrasound(10 days after start of ventilatory support)
  • Early or late extubation failure rate (extubation performed before or after 48 hours)(The last day of hospitalisation)
  • Length of ventilation in hours(10 days after start of ventilatory support)
  • Drug administration(10 days after start of ventilatory support)
  • Total positive end expiratory pressure(10 days after start of ventilatory support)
  • Highest expiratory pressure level(10 days after start of ventilatory support)
  • External positive end expiratory pressure(10 days after start of ventilatory support)
  • Volume of exhaled air(10 days after start of ventilatory support)

研究者

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

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