Long Term (1 Year) Respiratory Sequelae in Children Surviving Acute Respiratory Distress Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 10
- 主要终点
- Dynamic lung compliance
研究概览
简要总结
The purpose of this study is to assess long term (1 year) respiratory sequelae in children surviving an acute respiratory distress syndrome
详细描述
The acute respiratory distress syndrome (ARDS) has a high mortality rate in children. Adverse long term sequelae, and in particular respiratory sequelae, have been described mainly in adults. Decrease in diffusing capacity, lung volume and exercise tolerance were observed. Lung function parameters improve during the follow-up until 6 month after discharge from the pediatric intensive care unit (PICU). After that, abnormalities in PFT are observed in a significant proportion of patients. Only two studies described long-term sequelae in children surviving to an ARDS and their results are conflicting. Two studies carried out in adults described the morphologic long-term sequelae by thoracic computed tomography. They showed reticular pattern with a striking anterior distribution in most patients evaluated more than 6 months after discharge from the PICU. There is, to our knowledge, no study describing morphologic pulmonary sequelae by thoracic computed tomography in children surviving to ARDS.
Respiratory assessment: respiratory sequelae in children surviving to the acute respiratory distress syndrome will be evaluated 1 year after discharge from the PICU. Assessment will include a clinical evaluation (respiratory history and physical examination), respiratory function tests and thoracic computed tomography
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
- 1 Year 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children surviving to an acute respiratory distress syndrome and alive 1 year after discharge from the PICU
排除标准
- •children suffering from neuromuscular disease
- •children presenting symptoms of chronic respiratory disease before ARDS
结局指标
主要结局
Dynamic lung compliance
时间窗: 1 year +- 2 months after discharge from ICU
次要结局
- respiratory complaints (cough, wheeze,dypnea at rest on exertion, bronchitis, pneumonia(1 year +- 2 months after discharge from ICU)
- carbon monoxide diffusing capacity(1 year +- 2 months after discharge from ICU)
- extend of decreased attenuation attributable to small-airway disease(1 year +- 2 months after discharge from ICU)
- extend of ground glass opacification (CT scan)(1 year +- 2 months after discharge from ICU)
- extend of intense parenchymal opacification(1 year +- 2 months after discharge from ICU)
- extend of reticular pattern(1 year +- 2 months after discharge from ICU)
- extend of decreased attenuation due to emphysema(1 year +- 2 months after discharge from ICU)
- Pulse oxymetry oxygen saturation at the end of a 6 min walk test(1 year +- 2 months after discharge from ICU)