How to exactly measure lung volumes in healthy subjects and COPD patients, non-invasively
Recruiting
- Conditions
- healthy and COPD
- Registration Number
- NL-OMON22284
- Lead Sponsor
- Radboudumc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
In part 1, thirty healthy subject between 18-80 years are included, after signing informed consent. All subjects have a normal lung function (forced expiratory volume in 1 second (FEV1) > 80%).
Exclusion Criteria
In part 2, thirty COPD patients are included. All subjects have a lung function with FEV1 < 80%, corresponding to GOLD stage II-IV. Exclusion criteria, for both parts of the study, are physical impairment to perform physical tests, not fitting an available shirt, presence of a pacemaker or implantable cardioverter defibrillator, inability to read/understand Dutch language. And for COPD patients, an exacerbation within 1 month before inclusion is a exclusion criteria.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary study parameter will answer the main objective, can the Hexoskin shirt accurately measure volume relative to the gold standard (spirometer or Oxycon Mobile). This analysis is performed in healthy subjects and later on in COPD patients. The Bland-Altman plot will be plotted as a percentage instead of a absolute difference. And is calculated with: ((volumes Method A – volumes Method B) / mean volumes of both methods x 100%), in which Method A is the Hexoskin shirt and Method B spirometer or Oxycon Mobile
- Secondary Outcome Measures
Name Time Method repeatability of measurements in two sessions (ICC) <br /><br>effects of position and activity on the measurements with the Hexoskin (t-tests)<br /><br>bias calculated with the Bland-Altman plots <br /><br>Percentage error in volumes between Hexoskin shirt and gold standard<br /><br>experience of the subjects with the Hexoskin shirt