Clinical Trial: Long Term (1 Year) Respiratory Sequelae in Children Surviving an Acute Respiratory Distress Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Long Term (1 Year) Respiratory Sequelae in Children Surviving Acute Respiratory Distress Syndrome

Brief Summary: The purpose of this study is to assess long term (1 year) respiratory sequelae in children surviving an acute respiratory distress syndrome

Detailed Summary:

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


Sponsor: University Hospital, Lille

Current Primary Outcome: Dynamic lung compliance [ Time Frame: 1 year +- 2 months after discharge from ICU ]

Original Primary Outcome:

Current Secondary Outcome:

  • respiratory complaints (cough, wheeze,dypnea at rest on exertion, bronchitis, pneumonia [ Time Frame: 1 year +- 2 months after discharge from ICU ]
  • extend of ground glass opacification (CT scan) [ Time Frame: 1 year +- 2 months after discharge from ICU ]
  • extend of intense parenchymal opacification [ Time Frame: 1 year +- 2 months after discharge from ICU ]
  • extend of reticular pattern [ Time Frame: 1 year +- 2 months after discharge from ICU ]
  • extend of decreased attenuation due to emphysema [ Time Frame: 1 year +- 2 months after discharge from ICU ]
  • extend of decreased attenuation attributable to small-airway disease [ Time Frame: 1 year +- 2 months after discharge from ICU ]
  • carbon monoxide diffusing capacity [ Time Frame: 1 year +- 2 months after discharge from ICU ]
  • Pulse oxymetry oxygen saturation at the end of a 6 min walk test [ Time Frame: 1 year +- 2 months after discharge from ICU ]


Original Secondary Outcome:

Information By: University Hospital, Lille

Dates:
Date Received: September 16, 2011
Date Started: June 2006
Date Completion:
Last Updated: December 1, 2015
Last Verified: December 2015