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临床试验/NCT02851446
NCT02851446Unknown不适用

Prevalence and Risk Factors of Dreentilation Syndrome in a Population of Patients Under Ventilation for Whatever Reason

Centre Hospitalier Universitaire Dijon1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2015年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
300
试验地点
1
主要终点
presence of diagnostic criteria for reventilation Syndrome (dyspnoea > Borg 7)

研究概览

简要总结

Non-invasive nocturnal ventilation is an effective treatment for chronic respiratory failure, whether due to obstructive (COPD), restrictive or neuromuscular causes, notably for patients in the last two categories for whom it significantly prolongs life expectancy. Overall, the treatment is well tolerated, its principal adverse effects being discomfort related to the mask.

In certain patients, morning dyspnoea when the mask is removed has been described. This is disabling as it limits everyday activities for at least 30 minutes, and defines deventilation syndrome. The pathophysiology of this syndrome is uncertain, notably the roles of hyperinflation, patient/ventilator asynchrony, or the sudden increase in diaphragmatic work after a night of rest.

The aim of this study is to investigate the prevalence of and factors associated with reventilation syndrome (DS) in a population of patients with ventilation whatever the reason, in a stable state, and followed by the medical devices department of Dijon CHU, so as to better understand the mechanisms. Patients with DS will subsequently be invited to participate in a therapeutic trial.

研究设计

研究类型
Observational
观察模型
Case Control
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

  • patients over 18 years old
  • ventilation for whatever reason
  • in the ST mode
  • not in life support
  • at more than 1 month after the last episode of respiratory decompensation

排除标准

  • guardianship
  • inability to understand instructions and provide consent
  • uncontrolled psychiatric disease

结局指标

主要结局

presence of diagnostic criteria for reventilation Syndrome (dyspnoea > Borg 7)

时间窗: at withdrawal of the machine, disabling for everyday activities for at least 30 minutes after stopping the ventilation

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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