Cough Assist in Bronchiolitis

Bronchiolitis Clinical Trial

Official title:

Cough Assist in RSV-bronchiolitis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01757496
• Other study ID #: UZA-11/44/334
• Status: Terminated
• Phase: N/A
• Start date: September 2012
• Est. completion date: October 10, 2018

Study information

• Verified date: October 2018
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: October 10, 2018
• Est. primary completion date: October 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 18 Months

Eligibility

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.

Related Conditions & MeSH terms

• Bronchiolitis
• Respiratory Syncytial Virus

Intervention

Device:
• Cough Assist

Locations

Country	Name	City	State
Belgium	Antwerp University Hospital	Edegem
Belgium	GZA Sint-Augustinus	Wilrijk

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Antwerp	Philips Respironics

Country where clinical trial is conducted

Belgium, 

Outcome

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