Cough Assist in Bronchiolitis
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|ClinicalTrials.gov Identifier: NCT01757496|
Recruitment Status : Terminated (Difficulties with patient inclusion)
First Posted : December 31, 2012
Last Update Posted : October 15, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Bronchiolitis Respiratory Syncytial Virus||Device: Cough Assist||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cough Assist in RSV-bronchiolitis|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||October 10, 2018|
|Actual Study Completion Date :||October 10, 2018|
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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01757496
|Antwerp University Hospital|
|Edegem, Belgium, 2650|
|Wilrijk, Belgium, 2620|
|Principal Investigator:||Stijn Verhulst, MD, PhD||University Hospital, Antwerp|