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

Bronchiectasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00522314
• Other study ID #: 1233R020
• Status: Completed
• Phase: N/A
• First received: August 28, 2007
• Last updated: August 28, 2007
• Start date: October 2003
• Est. completion date: April 2006

Study information

• Verified date: August 2007
• Source: University of Ulster
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchiectasis

Intervention

Device:
• NIV and ACBT

Other:
• Active Cycle of Breathing Techniques

Locations

Country	Name	City	State
United Kingdom	Belfast City Hospital	Belfast	Northern Ireland

Sponsors (1)

Lead Sponsor	Collaborator
University of Ulster

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory muscle strength		Before; mid-way; on completion of intravenous antibiotics
Secondary	Sputum weight		During airway clearance; half hour after airway clearance; 24 hour sputum clearance
Secondary	Breathlessness		Before and after each airway clearance session
Secondary	respiratory mechanics (Vivometrics Lifeshirt)		On first and last airway clearance session