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临床试验/NCT02299986
NCT02299986已完成不适用

An InnovaTive Approach to Ventilator-Induced Diaphragmatic Dysfunction

University Hospital, Antwerp1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2013年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
56
试验地点
1
主要终点
Change in diaphragm thickness

研究概览

简要总结

'Ventilator-Induced Diaphragmatic Dysfunction (VIDD) was originally described by Vassilakopoulos and Petrof in 1998, where it is used to cover the effects of mechanical ventilation and respiratory muscle unloading on the diaphragm. A recent article by Grosu and colleagues has demonstrated that the thickness of the diaphragm decreases with about 6% a day in a small cohort of mechanically ventilated patients. This is a longitudinal, single-centre, observational cohort study to examine the long-term effects of invasive mechanical ventilation on the diaphragm, and to study the risk factors associated with VIDD.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • The patient must suffer from respiratory insufficiency requiring mechanical ventilation

排除标准

  • The patient has been hospitalized and mechanically ventilated (invasive or non- invasive) in the period up to 1 year before start of the study.
  • The patient is known or suspected to have an anatomical malformation of the diaphragm.
  • The patient suffers from a disease that may impair diaphragmatic function:
  • Central neural disease at the level of the brain (Multiple sclerosis, stroke, Arnold-Chiari malformation) and spinal cord (quadriplegia, amyotrophic lateral sclerosis, poliomyelitis, spinal muscular atrophy, syringomyelia).
  • Neural disease of the phrenic nerve (Guillain-Barré syndrome, tumor compression, neuralgic neuropathy, chronic inflammatory demyelinating polyneuropathy, Charcot-Marie-Tooth disease).
  • Disorders of the neuromuscular junction (Myasthenia gravis, Lambert- Eaton syndrome, botulism, organophosphate poisoning).
  • Muscular diseases (muscular dystrophies, myositis (infectious, inflammatory, metabolic).
  • The patient is known or suspected to have a psychiatric illness inhibiting his/her cooperation with the study protocol or possibly obscuring the obtained results.
  • The patient has been mechanically ventilated for over 24 hours before the first ultrasonographic measurement can be performed.

结局指标

主要结局

Change in diaphragm thickness

时间窗: Participants will be followed during their ICU stay, an expected average of 1 week

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tom Schepens, MD

MD

University Hospital, Antwerp

研究点 (1)

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