Cough Assist in Bronchiolitis

NCT ID: NCT01757496

Last Updated: 2018-10-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2018-10-10

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.

Conditions

Bronchiolitis; Respiratory Syncytial Virus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cough Assist

These children will receive 2 Cough Assist sessions daily.

Group Type: EXPERIMENTAL

Cough Assist

Intervention Type: DEVICE

Control group

These children receive standard care but no physiotherapy.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cough Assist

Intervention Type: DEVICE

Other Intervention Names

Philips-Respironics Cough Assist E70

Eligibility Criteria

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.

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 18 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Philips Respironics

INDUSTRY

Sponsor Role: collaborator

University Hospital, Antwerp

OTHER

Sponsor Role: lead

Responsible Party

Stijn Verhulst

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stijn Verhulst, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Antwerp

Locations

Antwerp University Hospital

Edegem, , Belgium

GZA Sint-Augustinus

Wilrijk, , Belgium

Countries

Belgium

Other Identifiers

UZA-11/44/334

Identifier Type: -

Identifier Source: org_study_id