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Cough Assist in Bronchiolitis

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ClinicalTrials.gov Identifier: NCT01757496
Recruitment Status : Terminated (Difficulties with patient inclusion)
First Posted : December 31, 2012
Last Update Posted : October 15, 2018
Sponsor:
Collaborator:
Philips Respironics
Information provided by (Responsible Party):
Stijn Verhulst, University Hospital, Antwerp

Tracking Information
First Submitted Date  ICMJE December 18, 2012
First Posted Date  ICMJE December 31, 2012
Last Update Posted Date October 15, 2018
Study Start Date  ICMJE September 2012
Actual Primary Completion Date October 10, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 22, 2012)
Oxygen requirement [ Time Frame: This will be investigated daily during hospitalization. The duration of hospitalization is estimated to 5-7 days. ]
Number of days needing additional oxygen requirement
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2012)
  • Atelectasis [ Time Frame: This will be investigated daily during hospitalization. The duration of hospitalization is estimated to 5-7 days. ]
    Development of atelectasis
  • Bronchoscopy [ Time Frame: This will be investigated daily during hospitalization. The duration of hospitalization is estimated to 5-7 days. ]
    Need for bronchoscopy
  • Hypercapnia [ Time Frame: This will be investigated daily during hospitalization. The duration of hospitalization is estimated to 5-7 days. ]
    Duration of hypercapnia
  • Hospitalization length [ Time Frame: This will be determined at the moment of discharge. Average hospitalization length is estimated to be 5-7 days. ]
    Hospitalization length
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cough Assist in Bronchiolitis
Official Title  ICMJE Cough Assist in RSV-bronchiolitis
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Bronchiolitis
  • Respiratory Syncytial Virus
Intervention  ICMJE Device: Cough Assist
Other Name: Philips-Respironics Cough Assist E70
Study Arms  ICMJE
  • Experimental: Cough Assist
    These children will receive 2 Cough Assist sessions daily.
    Intervention: Device: Cough Assist
  • No Intervention: Control group
    These children receive standard care but no physiotherapy.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Estimated Enrollment  ICMJE
 (submitted: October 10, 2018)
1
Original Estimated Enrollment  ICMJE
 (submitted: December 22, 2012)
20
Actual Study Completion Date  ICMJE October 10, 2018
Actual Primary Completion Date October 10, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Months to 18 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01757496
Other Study ID Numbers  ICMJE UZA-11/44/334
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Stijn Verhulst, University Hospital, Antwerp
Study Sponsor  ICMJE University Hospital, Antwerp
Collaborators  ICMJE Philips Respironics
Investigators  ICMJE
Principal Investigator: Stijn Verhulst, MD, PhD University Hospital, Antwerp
PRS Account University Hospital, Antwerp
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP