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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
University of Ulster
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiectasis focused on measuring Non-invasive ventilation, Airway clearance, Bronchiectasis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
August 28, 2007
Last Updated
August 28, 2007
Sponsor
University of Ulster
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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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