Status:
COMPLETED
Effect of Portable NIV on Operational Chest Wall Volumes in COPD
Lead Sponsor:
Northumbria University
Collaborating Sponsors:
North Tyneside General Hospital
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40+ years
Phase:
NA
Brief Summary
The VitaBreath (Philips, Respironics) is a portable, handheld, battery powered, non-invasive ventilation device, that has been shown to reduce activity-related shortness of breath in patients with COP...
Detailed Description
Study Design: This is a randomised crossover trial. Patients will perform two identical exercise tests and the intervention (VitaBreath) will be compared to control condition (pursed-lip breathing) i...
Eligibility Criteria
Inclusion
- Male or female aged 40 years or older.
- Current or previous smoking history: 10 or more pack years.
- Spirometry confirmed stable COPD (GOLD stages II-IV) under optimal medical therapy.
- Exhibit substantial exercise-induced dynamic hyperinflation (ΔIC baseline \> 0,150 L)
Exclusion
- Orthopaedic, neurological or other concomitant diseases that significantly impair normal biomechanical movement patterns, as judged by the investigator.
- Moderate or severe COPD exacerbation within 6 weeks.
- Unstable cardiac arrhythmia.
- Unstable ischaemic heart disease, including myocardial infarction within 6 weeks.
- Moderate or severe aortic stenosis or hypertrophic obstructive cardiomyopathy.
- Uncontrolled hypertension.
- Uncontrolled hypotension (SBP\<85mmHg).
- Uncontrolled diabetes.
- Intolerance of the VitaBreath device.
Key Trial Info
Start Date :
July 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 29 2020
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT03848819
Start Date
July 1 2019
End Date
February 29 2020
Last Update
September 11 2020
Active Locations (1)
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1
Northumbria University
Newcastle upon Tyne, United Kingdom, NE1 8ST