Clinical trial NCT01757496: Cough Assist in Bronchiolitis
Official title: Cough Assist in RSV-bronchiolitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Bronchiolitis
Respiratory Syncytial Virus
Keywords: Bronchiolitis
Respiratory Syncytial Virus
Cough Assist
Physiotherapy
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
Collaborators: name: Philips Respironics
First posted: 2012-12-31
Enrollment: 1
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Oxygen requirement
timeFrame: This will be investigated daily during hospitalization. The duration of hospitalization is estimated to 5-7 days.
Secondary outcomes:
measure: Atelectasis
timeFrame: This will be investigated daily during hospitalization. The duration of hospitalization is estimated to 5-7 days.
measure: Bronchoscopy
timeFrame: This will be investigated daily during hospitalization. The duration of hospitalization is estimated to 5-7 days.
measure: Hypercapnia
timeFrame: This will be investigated daily during hospitalization. The duration of hospitalization is estimated to 5-7 days.
measure: Hospitalization length
timeFrame: This will be determined at the moment of discharge. Average hospitalization length is estimated to be 5-7 days.
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Antwerp University Hospital
city: Wilrijk
country: Belgium
facility: GZA Sint-Augustinus
Study officials:
affiliation: University Hospital, Antwerp
name: Stijn Verhulst, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: