Cough Assist in Bronchiolitis

NCT01757496 | Terminated

• 1 other identifier: UZA-11/44/334
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 2

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

Keywords

Bronchiolitis; Respiratory Syncytial Virus; Cough Assist; Physiotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Atelectasis

  This will be investigated daily during hospitalization. The duration of hospitalization is estimated to 5-7 days.

• Bronchoscopy

  This will be investigated daily during hospitalization. The duration of hospitalization is estimated to 5-7 days.

• Hypercapnia

  This will be investigated daily during hospitalization. The duration of hospitalization is estimated to 5-7 days.

• Hospitalization length

  This will be determined at the moment of discharge. Average hospitalization length is estimated to be 5-7 days.

Study Arms (2)

Cough Assist

EXPERIMENTAL

These children will receive 2 Cough Assist sessions daily.

Device: Cough Assist

Control group

NO INTERVENTION

These children receive standard care but no physiotherapy.

Interventions

Cough Assist DEVICE

Also known as: Philips-Respironics Cough Assist E70

Cough Assist

Eligibility Criteria

• Age: 3 Months - 18 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Antwerp: lead
• Philips Respironics: collaborator

Study Sites (2)

Antwerp University Hospital

Edegem, 2650, Belgium

Location

GZA Sint-Augustinus

Wilrijk, 2620, Belgium

Location

MeSH Terms

Conditions

Bronchiolitis

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Officials

• Stijn Verhulst, MD, PhD

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: December 18, 2012
• First Posted: December 31, 2012
• Study Start: September 1, 2012
• Primary Completion: October 10, 2018
• Study Completion: October 10, 2018
• Last Updated: October 15, 2018

Record last verified: 2018-10

Locations

BE (2)