How to exactly measure lung volumes in healthy subjects and COPD patients, non-invasively?

Completed

Conditions: COPD
10024967
gezonde luchtwegen
chronic obstructive pulmonary disease

Registration Number: NL-OMON50486

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 60

Inclusion Criteria

Healthy subjects:
- Healthy, adult subjects between the age of 18 - 80 years.
- Normal lung function (FEV1 > 80%)
- Written informed consent prior to participation.
COPD patients:
- Patients with stable COPD. FEV1 < 80% predicted (GOLD stage II-IV).
- Written informed consent prior to participation.

Exclusion Criteria

- Exacerbation within 1 month before inclusion
- Physical impairment causing any disability to perform physical tests
- Subjects who do not fit one of the available shirts
- Subjects with a pacemaker/ ICD device
- Inability to read and/or understand the Dutch language

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter will answer the main objective, can the Hexoskin shirt<br /><br>measure volume relative to the gold standard (spirometer / mobile spirometer),<br /><br>valide. For measurement A and B (position and activity measurements) the mobile<br /><br>spirometer (Oxycon Mobile) will be the gold standard, per subject more tidal<br /><br>volumes are calculated and will be compared between both methods. The<br /><br>Bland-Altman is calculated overall (measurement A and B together) and per<br /><br>task/activity. For measurement C and D (lung function tests), a spirometer or<br /><br>bodybox is the gold standard, per subject one value of IC or EELV, FEV1, VC and<br /><br>FVC are used for the Bland-Altman plots. In both parts of the study, a 95% CI<br /><br>below 15% difference will indicate that the Hexoskin shirt can validly measure<br /><br>volumes. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary parameters are intra class correlation coefficient for reliability,<br /><br>mixed modesl repeated measurement analyse to find differences in calibration<br /><br>parameters for the various tasks, systematic error by means of the bias,<br /><br>percentage error of the volumes, correlation between demographic parameters and<br /><br>percentage error, and the experience with the Hexoskin shirt.</p><br>