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| Sponsored by: |
University of Ulster |
|---|---|
| Information provided by: | University of Ulster |
| ClinicalTrials.gov Identifier: | NCT00522314 |
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: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Airway Clearance in Bronchiectasis: is Non-Invasive Ventilation a Useful Adjunct in Moderate to Severe Disease?A Pilot Study. |
| Enrollment: | 20 |
| Study Start Date: | October 2003 |
| Study Completion Date: | April 2006 |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
NIV & ACBT
|
Device: NIV and ACBT |
|
2: Placebo Comparator
Active cycle of breathing techniques
|
Other: Active Cycle of Breathing Techniques |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United Kingdom, Northern Ireland | |
| Belfast City Hospital | |
| Belfast, Northern Ireland, United Kingdom, BT 9 7AB | |
| Principal Investigator: | Prof Elborn, MD | Belfast City Hospital and Queens University Belfast |
More Information
| Study ID Numbers: | 1233R020 |
| Study First Received: | August 28, 2007 |
| Last Updated: | August 28, 2007 |
| ClinicalTrials.gov Identifier: | NCT00522314 History of Changes |
| Health Authority: | United Kingdom: Department of Health |
|
Non-invasive ventilation Airway clearance Bronchiectasis |
|
Respiratory Tract Diseases Bronchial Diseases Bronchiectasis |
|
Respiratory Tract Diseases Bronchial Diseases Bronchiectasis |
