Cough Assist in Bronchiolitis
Primary Purpose
Bronchiolitis, Respiratory Syncytial Virus
Status
Terminated
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Cough Assist
Sponsored by
About this trial
This is an interventional treatment trial for Bronchiolitis focused on measuring Bronchiolitis, Respiratory Syncytial Virus, Cough Assist, Physiotherapy
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.
Sites / Locations
- Antwerp University Hospital
- GZA Sint-Augustinus
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Cough Assist
Control group
Arm Description
These children will receive 2 Cough Assist sessions daily.
These children receive standard care but no physiotherapy.
Outcomes
Primary Outcome Measures
Oxygen requirement
Number of days needing additional oxygen requirement
Secondary Outcome Measures
Atelectasis
Development of atelectasis
Bronchoscopy
Need for bronchoscopy
Hypercapnia
Duration of hypercapnia
Hospitalization length
Hospitalization length
Full Information
NCT ID
NCT01757496
First Posted
December 18, 2012
Last Updated
October 10, 2018
Sponsor
University Hospital, Antwerp
Collaborators
Philips Respironics
1. Study Identification
Unique Protocol Identification Number
NCT01757496
Brief Title
Cough Assist in Bronchiolitis
Official Title
Cough Assist in RSV-bronchiolitis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Terminated
Why Stopped
Difficulties with patient inclusion
Study Start Date
September 2012 (undefined)
Primary Completion Date
October 10, 2018 (Actual)
Study Completion Date
October 10, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Antwerp
Collaborators
Philips Respironics
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis, Respiratory Syncytial Virus
Keywords
Bronchiolitis, Respiratory Syncytial Virus, Cough Assist, Physiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cough Assist
Arm Type
Experimental
Arm Description
These children will receive 2 Cough Assist sessions daily.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
These children receive standard care but no physiotherapy.
Intervention Type
Device
Intervention Name(s)
Cough Assist
Other Intervention Name(s)
Philips-Respironics Cough Assist E70
Primary Outcome Measure Information:
Title
Oxygen requirement
Description
Number of days needing additional oxygen requirement
Time Frame
This will be investigated daily during hospitalization. The duration of hospitalization is estimated to 5-7 days.
Secondary Outcome Measure Information:
Title
Atelectasis
Description
Development of atelectasis
Time Frame
This will be investigated daily during hospitalization. The duration of hospitalization is estimated to 5-7 days.
Title
Bronchoscopy
Description
Need for bronchoscopy
Time Frame
This will be investigated daily during hospitalization. The duration of hospitalization is estimated to 5-7 days.
Title
Hypercapnia
Description
Duration of hypercapnia
Time Frame
This will be investigated daily during hospitalization. The duration of hospitalization is estimated to 5-7 days.
Title
Hospitalization length
Description
Hospitalization length
Time Frame
This will be determined at the moment of discharge. Average hospitalization length is estimated to be 5-7 days.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stijn Verhulst, MD, PhD
Organizational Affiliation
University Hospital, Antwerp
Official's Role
Principal Investigator
Facility Information:
Facility Name
Antwerp University Hospital
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
GZA Sint-Augustinus
City
Wilrijk
ZIP/Postal Code
2620
Country
Belgium
12. IPD Sharing Statement
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Cough Assist in Bronchiolitis
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