跳至主要内容
临床试验/NCT01757496
NCT01757496终止不适用

Cough Assist in RSV-bronchiolitis

University Hospital, Antwerp4 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2012年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
1
试验地点
4
主要终点
Oxygen requirement

研究概览

简要总结

RSV bronchiolitis in children is still associated with significant morbidity and mortality. RSV infection results in increased mucus production, edema and inflammation at the lower airways and impaired mucociliary clearance. Infants and children under the age of 1 year are particularly vulnerable to complications such as atelectasis and secondary bacterial infection. These children often need non-invasive or invasive ventilation. Atelectasis is common in these children because of smaller airways and decreased cough strength. There is still much uncertainty about the treatment of RSV. Treatment consists primarily of supportive therapy such as tube feeding and additional respiratory support if necessary. There is also limited evidence about the use of nebulizers with beta-agonists and/or hypertonic saline.

The cough assist is a mechanical in- and exsufflator used primarily in patients with neuromuscular diseases to augment cough capacity. In these patients, it was demonstrated that the use of assisted cough resulted in a significant decrease in the number of respiratory infections. Moreover, there is evidence that when used in the case of an acute respiratory deterioration such a massive atelectasis, the atelectasis can be corrected and intubation can be avoided. The aim of this study is to investigate if the use of the CoughAssist device in children with RSV bronchiolitis is associated with a better respiratory outcome.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
3 Months 至 18 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Children between 3 and 18 months admitted to our hospital with a clinical diagnosis of bronchiolitis in the RSV season or with a positive nasopharyngeal aspirate for RSV.

排除标准

  • Children with congenital cardiac disease.
  • Children with cystic fibrosis.
  • Children with reactive airways disease.
  • Children with neurological impairment including cerebral palsy.
  • Children with neuromuscular disease.
  • Children with upper GI surgery.
  • Children with emphysema.
  • Children with a known susceptibility to pneumothorax or with a pneumothorax in the past.

研究组 & 干预措施

Cough Assist

Experimental

These children will receive 2 Cough Assist sessions daily.

干预措施: Cough Assist (Device)

Control group

No Intervention

These children receive standard care but no physiotherapy.

结局指标

主要结局

Oxygen requirement

时间窗: This will be investigated daily during hospitalization. The duration of hospitalization is estimated to 5-7 days.

Number of days needing additional oxygen requirement

次要结局

  • Atelectasis(This will be investigated daily during hospitalization. The duration of hospitalization is estimated to 5-7 days.)
  • Bronchoscopy(This will be investigated daily during hospitalization. The duration of hospitalization is estimated to 5-7 days.)
  • Hypercapnia(This will be investigated daily during hospitalization. The duration of hospitalization is estimated to 5-7 days.)
  • Hospitalization length(This will be determined at the moment of discharge. Average hospitalization length is estimated to be 5-7 days.)

研究者

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

Stijn Verhulst

MD, PhD

University Hospital, Antwerp

研究点 (4)

Loading locations...

相似试验