Cough Assist in Bronchiolitis

Antwerp University Hospital (UZA)

Status

Terminated

Conditions

Respiratory Syncytial Virus

Bronchiolitis

Treatments

Device: Cough Assist

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01757496

UZA-11/44/334

Details and patient eligibility

About

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.

Enrollment

1 estimated patient

Sex

All

Ages

3 to 18 months old

Volunteers

No Healthy Volunteers

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.