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

This study has been completed.
Sponsor:
Information provided by:
University of Ulster
ClinicalTrials.gov Identifier:
NCT00522314
First received: August 28, 2007
Last updated: NA
Last verified: August 2007
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00522314     History of Changes
Other Study ID Numbers: 1233R020
Study First Received: August 28, 2007
Last Updated: August 28, 2007
Health Authority: United Kingdom: Department of Health

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

Additional relevant MeSH terms:
Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 30, 2014