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Completed

NCT Number: NCT00522314

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

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.

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Key information

Conditions

Bronchiectasis Bronchial Diseases Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Belfast City Hospital

Belfast, Northern Ireland, BT 9 7AB, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NIV and ACBT

Device

ACTIVE CYCLE OF BREATHING TECHNIQUES

Other

Primary outcomes

  1. Respiratory muscle strength

    Time frame: Before; mid-way; on completion of intravenous antibiotics

Secondary outcomes

  1. Sputum weight

    Time frame: During airway clearance; half hour after airway clearance; 24 hour sputum clearance

  2. Breathlessness

    Time frame: Before and after each airway clearance session

  3. respiratory mechanics (Vivometrics Lifeshirt)

    Time frame: On first and last airway clearance session

Sponsors and collaborators

Lead sponsor

University of Ulster

Other

Registry information

Official study title

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

Important dates

Study start
2003
Study completion
2006
First posted
Aug 29, 2007
Registry last updated
Aug 29, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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