Cough Assist in Bronchiolitis

Cough Assist in RSV-bronchiolitis

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.

Study Overview

• Status: Terminated
• Conditions: Bronchiolitis; Respiratory Syncytial Virus
• Intervention / Treatment: Device: Cough Assist

• Study Type: Interventional
• Enrollment (Anticipated): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Edegem, Belgium, 2650
    • Antwerp University Hospital
  • Wilrijk, Belgium, 2620
    • GZA Sint-Augustinus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 1 year (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Cough Assist; These children will receive 2 Cough Assist sessions daily.	Device: Cough Assist; Other Names: Philips-Respironics Cough Assist E70
NO_INTERVENTION: Control group; These children receive standard care but no physiotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Antwerp
• Collaborators: Philips Respironics

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (ACTUAL): October 10, 2018
• Study Completion (ACTUAL): October 10, 2018

Study Registration Dates

• First Submitted: December 18, 2012
• First Submitted That Met QC Criteria: December 22, 2012
• First Posted (ESTIMATE): December 31, 2012

Study Record Updates

• Last Update Posted (ACTUAL): October 15, 2018
• Last Update Submitted That Met QC Criteria: October 10, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Physiotherapy; Respiratory Syncytial Virus; Bronchiolitis; Cough Assist
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchitis; Bronchiolitis
• Other Study ID Numbers: UZA-11/44/334