Cough Assist in Bronchiolitis

Study Overview
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Brief Summary
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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.

Official Title
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Cough Assist in RSV-bronchiolitis

Conditions
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Bronchiolitis, Respiratory Syncytial Virus

Intervention / Treatment
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* Device: Cough Assist


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 18 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cough Assist<br>These children will receive 2 Cough Assist sessions daily. | Device: Cough Assist<br> <br> * Other names: Philips-Respironics Cough Assist E70;|
| No Intervention: Control group<br>These children receive standard care but no physiotherapy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygen requirement | Number of days needing additional oxygen requirement | This will be investigated daily during hospitalization. The duration of hospitalization is estimated to 5-7 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atelectasis | Development of atelectasis | This will be investigated daily during hospitalization. The duration of hospitalization is estimated to 5-7 days. | 
| Bronchoscopy | Need for bronchoscopy | This will be investigated daily during hospitalization. The duration of hospitalization is estimated to 5-7 days. | 
| Hypercapnia | Duration of hypercapnia | This will be investigated daily during hospitalization. The duration of hospitalization is estimated to 5-7 days. | 
| Hospitalization length | Hospitalization length | This will be determined at the moment of discharge. Average hospitalization length is estimated to be 5-7 days. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bronchiolitis, Respiratory Syncytial Virus, Cough Assist, Physiotherapy