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

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

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.

Study Overview

• Status: Completed
• Conditions: Bronchiectasis
• Intervention / Treatment: Device: NIV and ACBT; 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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Northern Ireland
    • Belfast, Northern Ireland, United Kingdom, BT 9 7AB
      • Belfast City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; NIV & ACBT	Device: NIV and ACBT
Placebo Comparator: 2; Active cycle of breathing techniques	Other: Active Cycle of Breathing Techniques

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Respiratory muscle strength	Before; mid-way; on completion of intravenous antibiotics

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Ulster
• Investigators: Principal Investigator: Prof Elborn, MD, Belfast City Hospital and Queens University Belfast

Study record dates

Study Major Dates

• Study Start: October 1, 2003
• Study Completion (Actual): April 1, 2006

Study Registration Dates

• First Submitted: August 28, 2007
• First Submitted That Met QC Criteria: August 28, 2007
• First Posted (Estimate): August 29, 2007

Study Record Updates

• Last Update Posted (Estimate): August 29, 2007
• Last Update Submitted That Met QC Criteria: August 28, 2007
• Last Verified: August 1, 2007

More Information

Terms related to this study

• Keywords: Non-invasive ventilation; Bronchiectasis; Airway clearance
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Bronchial Diseases; Bronchiectasis
• Other Study ID Numbers: 1233R020