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Airway Clearance in Bronchiectasis: is Non-Invasive Ventilation a Useful Adjunct in Moderate to Severe Disease?

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00522314
First Posted: August 29, 2007
Last Update Posted: August 29, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Ulster
  Purpose
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.

Condition Intervention
Bronchiectasis Device: NIV and ACBT Other: Active Cycle of Breathing Techniques

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Airway Clearance in Bronchiectasis: is Non-Invasive Ventilation a Useful Adjunct in Moderate to Severe Disease?A Pilot Study.

Further study details as provided by University of Ulster:

Primary Outcome Measures:
  • Respiratory muscle strength [ Time Frame: Before; mid-way; on completion of intravenous antibiotics ]

Secondary Outcome Measures:
  • Sputum weight [ Time Frame: During airway clearance; half hour after airway clearance; 24 hour sputum clearance ]
  • Breathlessness [ Time Frame: Before and after each airway clearance session ]
  • respiratory mechanics (Vivometrics Lifeshirt) [ Time Frame: On first and last airway clearance session ]

Enrollment: 20
Study Start Date: October 2003
Study Completion Date: April 2006
Arms Assigned Interventions
Active Comparator: 1
NIV & ACBT
Device: NIV and ACBT
Placebo Comparator: 2
Active cycle of breathing techniques
Other: Active Cycle of Breathing Techniques

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00522314


Locations
United Kingdom
Belfast City Hospital
Belfast, Northern Ireland, United Kingdom, BT 9 7AB
Sponsors and Collaborators
University of Ulster
Investigators
Principal Investigator: Prof Elborn, MD Belfast City Hospital and Queens University Belfast
  More Information

ClinicalTrials.gov Identifier: NCT00522314     History of Changes
Other Study ID Numbers: 1233R020
First Submitted: August 28, 2007
First Posted: August 29, 2007
Last Update Posted: August 29, 2007
Last Verified: August 2007

Keywords provided by University of Ulster:
Non-invasive ventilation
Airway clearance
Bronchiectasis

Additional relevant MeSH terms:
Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases