Cough Assist in Bronchiolitis
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Cough Assist in RSV-bronchiolitis|
- Oxygen requirement [ Time Frame: This will be investigated daily during hospitalization. The duration of hospitalization is estimated to 5-7 days. ]Number of days needing additional oxygen requirement
- Atelectasis [ Time Frame: This will be investigated daily during hospitalization. The duration of hospitalization is estimated to 5-7 days. ]Development of atelectasis
- Bronchoscopy [ Time Frame: This will be investigated daily during hospitalization. The duration of hospitalization is estimated to 5-7 days. ]Need for bronchoscopy
- Hypercapnia [ Time Frame: This will be investigated daily during hospitalization. The duration of hospitalization is estimated to 5-7 days. ]Duration of hypercapnia
- Hospitalization length [ Time Frame: This will be determined at the moment of discharge. Average hospitalization length is estimated to be 5-7 days. ]Hospitalization length
|Study Start Date:||September 2012|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
Experimental: Cough Assist
These children will receive 2 Cough Assist sessions daily.
Device: Cough Assist
Other Name: Philips-Respironics Cough Assist E70
No Intervention: Control group
These children receive standard care but no physiotherapy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01757496
|Antwerp University Hospital|
|Edegem, Belgium, 2650|
|Wilrijk, Belgium, 2620|
|Principal Investigator:||Stijn Verhulst, MD, PhD||University Hospital, Antwerp|