Cough Assist in Bronchiolitis
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Purpose
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 | Intervention |
|---|---|
|
Bronchiolitis Respiratory Syncytial Virus |
Device: Cough Assist |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Cough Assist in RSV-bronchiolitis |
- Oxygen requirement [ Time Frame: This will be investigated daily during hospitalization. The duration of hospitalization is estimated to 5-7 days. ] [ Designated as safety issue: No ]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. ] [ Designated as safety issue: No ]Development of atelectasis
- Bronchoscopy [ Time Frame: This will be investigated daily during hospitalization. The duration of hospitalization is estimated to 5-7 days. ] [ Designated as safety issue: No ]Need for bronchoscopy
- Hypercapnia [ Time Frame: This will be investigated daily during hospitalization. The duration of hospitalization is estimated to 5-7 days. ] [ Designated as safety issue: No ]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. ] [ Designated as safety issue: No ]Hospitalization length
| Estimated Enrollment: | 20 |
| Study Start Date: | September 2012 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 3 Months to 18 Months |
| Genders Eligible for Study: | Both |
| Accepts 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.
Contacts and Locations| Contact: Stijn Verhulst, MD, PhD | +3228213251 | stijn.verhulst@uza.be |
| Belgium | |
| Antwerp University Hospital | Recruiting |
| Edegem, Belgium, 2650 | |
| Contact: Stijn Verhulst, MD, PhD +3228213251 stijn.verhulst@uza.be | |
| Principal Investigator: Stijn Verhulst, MD, PhD | |
| Principal Investigator: | Stijn Verhulst, MD, PhD | University Hospital, Antwerp |
More Information
No publications provided
| Responsible Party: | Stijn Verhulst, MD, PhD, University Hospital, Antwerp |
| ClinicalTrials.gov Identifier: | NCT01757496 History of Changes |
| Other Study ID Numbers: | UZA-11/44/334 |
| Study First Received: | December 18, 2012 |
| Last Updated: | December 22, 2012 |
| Health Authority: | Institutional Review Board: Belgium Belgium: Federal Agency for Medicinal Products and Health Products |
Keywords provided by University Hospital, Antwerp:
|
Bronchiolitis Respiratory Syncytial Virus Cough Assist Physiotherapy |
Additional relevant MeSH terms:
|
Bronchiolitis Bronchitis Bronchial Diseases Respiratory Tract Diseases |
Lung Diseases, Obstructive Lung Diseases Respiratory Tract Infections |
ClinicalTrials.gov processed this record on May 21, 2013