Airway Clearance in Bronchiectasis: is Non-Invasive Ventilation a Useful Adjunct in Moderate to Severe Disease?
Primary Purpose
Bronchiectasis
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
NIV and ACBT
Active Cycle of Breathing Techniques
Sponsored by
About this trial
This is an interventional treatment trial for Bronchiectasis focused on measuring Non-invasive ventilation, Airway clearance, Bronchiectasis
Eligibility Criteria
Inclusion Criteria:
- Moderate to severe bronchiectasis (FEV1 < 60%),
- Indicators of difficulty expectorating sputum, and
- An acute exacerbation requiring intravenous antibiotics (IVAB)
Exclusion Criteria:
- Unable to tolerate positive pressure
- Presence of pneumothorax
Sites / Locations
- Belfast City Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
NIV & ACBT
Active cycle of breathing techniques
Outcomes
Primary Outcome Measures
Respiratory muscle strength
Secondary Outcome Measures
Sputum weight
Breathlessness
respiratory mechanics (Vivometrics Lifeshirt)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00522314
Brief Title
Airway Clearance in Bronchiectasis: is Non-Invasive Ventilation a Useful Adjunct in Moderate to Severe Disease?
Official Title
Airway Clearance in Bronchiectasis: is Non-Invasive Ventilation a Useful Adjunct in Moderate to Severe Disease?A Pilot Study.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2007
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Ulster
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This clinical trial is investigating the efficacy of Non Invasive Ventilation (NIV) as a method of airway clearance in patients with an acute exacerbation and moderate to severe bronchiectasis disease. Current treatment focuses on the use of Active Cycle of Breathing Techniques (ACBT) but this modality alone may not be sufficient when patients have more severe disease and an acute infection. The use of NIV may result in better patient care and more appropriate physiotherapy treatment in the more unwell population.The aim of this study is to compare the efficacy of two physiotherapy airways clearance interventions in bronchiectasis.
Detailed Description
Twenty patients with moderate to severe bronchiectasis admitted to hospital with an acute exacerbation were recruited (October 2004 to April 2006) and allocated to one of two groups that received twice daily airway clearance treatment for a course of IVAB. Group 1 {ACBT} and group 2 {NIV and ACBT}. A number of measurements were recorded on the first and final day of treatment as well as daily to provide important comparative information on physiological changes, ease of use, and clinical efficacy.
Outcomes measured on day 1 and final day of IVAB were: LifeshirtTM which recorded tidal volume; respiratory rate; airway flow; thoracoabdominal coordination; oxygen saturation and heart rate during treatment; respiratory muscle strength (PImax and PEmax); spirometry; arterial blood gases (ABGs); breathlessness scores; patients perception of tiredness, benefit and ease of treatment; auscultation; number of coughs per treatment; duration of treatment; sputum production, wet and dry weight; sputum rheology.
The Lifeshirt is a novel technique (respiratory induction plethysmography)which provides data on a wide range of dynamic lung function values (lung volumes; flow volume curves; relative excursion of rib cage and abdomen; SpO2) during airway clearance intervention to help understanding of the possible mechanisms of action of different airway clearance mechanisms.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiectasis
Keywords
Non-invasive ventilation, Airway clearance, Bronchiectasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
NIV & ACBT
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Active cycle of breathing techniques
Intervention Type
Device
Intervention Name(s)
NIV and ACBT
Intervention Type
Other
Intervention Name(s)
Active Cycle of Breathing Techniques
Primary Outcome Measure Information:
Title
Respiratory muscle strength
Time Frame
Before; mid-way; on completion of intravenous antibiotics
Secondary Outcome Measure Information:
Title
Sputum weight
Time Frame
During airway clearance; half hour after airway clearance; 24 hour sputum clearance
Title
Breathlessness
Time Frame
Before and after each airway clearance session
Title
respiratory mechanics (Vivometrics Lifeshirt)
Time Frame
On first and last airway clearance session
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Moderate to severe bronchiectasis (FEV1 < 60%),
Indicators of difficulty expectorating sputum, and
An acute exacerbation requiring intravenous antibiotics (IVAB)
Exclusion Criteria:
Unable to tolerate positive pressure
Presence of pneumothorax
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof Elborn, MD
Organizational Affiliation
Belfast City Hospital and Queens University Belfast
Official's Role
Principal Investigator
Facility Information:
Facility Name
Belfast City Hospital
City
Belfast
State/Province
Northern Ireland
ZIP/Postal Code
BT 9 7AB
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Airway Clearance in Bronchiectasis: is Non-Invasive Ventilation a Useful Adjunct in Moderate to Severe Disease?
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