Cough Assist in Bronchiolitis

Not Applicable

Terminated

• Conditions: Respiratory Syncytial Virus; Bronchiolitis
• Interventions: Device: Cough Assist

• Registration Number: NCT01757496
• Lead Sponsor: University Hospital, Antwerp

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-12-18
• Study First Submitted QC: 2012-12-22
• Study First Posted: 2012-12-31
• Status Verified: 2018-10
• Primary Completion: 2018-10-10
• Study Completion: 2018-10-10
• Last Update Submitted: 2018-10-10
• Last Update Posted: 2018-10-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cough Assist	Cough Assist	These children will receive 2 Cough Assist sessions daily.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

GZA Sint-Augustinus; 🇧🇪 Wilrijk, Belgium

Antwerp University Hospital; 🇧🇪 Edegem, Belgium