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

Not Applicable

Completed

• Conditions: Bronchiectasis
• Interventions: Device: NIV and ACBT; Other: Active Cycle of Breathing Techniques

• Registration Number: NCT00522314
• Lead Sponsor: University of Ulster

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.

Study Timeline

• Study Start: 2003-10
• Study Completion: 2006-04
• Status Verified: 2007-08
• Study First Submitted: 2007-08-28
• Study First Submitted QC: 2007-08-28
• Last Update Submitted: 2007-08-28
• Study First Posted: 2007-08-29
• Last Update Posted: 2007-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	NIV and ACBT	NIV \& ACBT
2	Active Cycle of Breathing Techniques	Active cycle of breathing techniques

Primary Outcome Measures

Name	Time	Method
Respiratory muscle strength	Before; mid-way; on completion of intravenous antibiotics

Secondary Outcome Measures

Name	Time	Method
Sputum weight	During airway clearance; half hour after airway clearance; 24 hour sputum clearance
Breathlessness	Before and after each airway clearance session
respiratory mechanics (Vivometrics Lifeshirt)	On first and last airway clearance session

Trial Locations

Locations (1)

Belfast City Hospital; 🇬🇧 Belfast, Northern Ireland, United Kingdom