Bronchiolitis, Respiratory Syncytial Virus
Conditions
Keywords
Bronchiolitis, Respiratory Syncytial Virus, Cough Assist, Physiotherapy
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.
Interventions
DEVICECough Assist
Sponsors
Philips Respironics
University Hospital, Antwerp
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Months to 18 Months
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oxygen requirement | This will be investigated daily during hospitalization. The duration of hospitalization is estimated to 5-7 days. | Number of days needing additional oxygen requirement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Atelectasis | This will be investigated daily during hospitalization. The duration of hospitalization is estimated to 5-7 days. | Development of atelectasis |
| Bronchoscopy | This will be investigated daily during hospitalization. The duration of hospitalization is estimated to 5-7 days. | Need for bronchoscopy |
| Hypercapnia | This will be investigated daily during hospitalization. The duration of hospitalization is estimated to 5-7 days. | Duration of hypercapnia |
| Hospitalization length | This will be determined at the moment of discharge. Average hospitalization length is estimated to be 5-7 days. | Hospitalization length |
Countries
Belgium
Outcome results
None listed