The primary objective is to investigate the validity of the volumes measured by the Hexoskin shirt relative to a (mobile) spirometer in healthy subjects and in COPD patients. Secondary objective are to determine reliability of the Hexoskin shirt…
ID
Source
Brief title
Condition
- Other condition
- Lower respiratory tract disorders (excl obstruction and infection)
Synonym
Health condition
gezonde luchtwegen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter will answer the main objective, can the Hexoskin shirt
measure volume relative to the gold standard (spirometer / mobile spirometer),
valide. For measurement A and B (position and activity measurements) the mobile
spirometer (Oxycon Mobile) will be the gold standard, per subject more tidal
volumes are calculated and will be compared between both methods. The
Bland-Altman is calculated overall (measurement A and B together) and per
task/activity. For measurement C and D (lung function tests), a spirometer or
bodybox is the gold standard, per subject one value of IC or EELV, FEV1, VC and
FVC are used for the Bland-Altman plots. In both parts of the study, a 95% CI
below 15% difference will indicate that the Hexoskin shirt can validly measure
volumes.
Secondary outcome
Secondary parameters are intra class correlation coefficient for reliability,
mixed modesl repeated measurement analyse to find differences in calibration
parameters for the various tasks, systematic error by means of the bias,
percentage error of the volumes, correlation between demographic parameters and
percentage error, and the experience with the Hexoskin shirt.
Background summary
COPD patients have problems with their breathing, and develop DH. DH is
correlated to the dyspnea sensation, as experienced by the subjects. The gold
standard to measure DH, is with use of a spirometer and by performing a
breathing manoevre (inspiratory capacity manoevre) before and after exercise.
This gold standard has a number of dis-advantages: (1) active participation of
a subject is necessary, (2) because of the exercise, patients are fatigued and
this can have an influence on the measured inspirotory capacity, (3) DH can not
be assessed continuously, (4) DH can not be assessed in the home situation. A
promising technique, which is able to measure long volumes and possibly DH, is
respiratory inductance plethysmography (RIP). These sensors, relate a change in
circumference of the thorax and abdomen to the inspiratory or expiratory
volume. Before this technique can be used in clinical practice/ home situation,
the measured long volumes have to be compared to a gold standard and have to be
repeatable. The RIP sensors are placed in a shirt, the Hexoskin shirt.
Study objective
The primary objective is to investigate the validity of the volumes measured by
the Hexoskin shirt relative to a (mobile) spirometer in healthy subjects and in
COPD patients. Secondary objective are to determine reliability of the Hexoskin
shirt measurement, the correlation with spirometer, effects of position and
activity, reliability of the Hexoskin shirt to measure DH and to investigate
the subjects experience with the Hexoskin shirt.
Study design
The study is divided into two parts. The first part is a pilot study, the
second part is a cross-sectional study. If part 1 shows poor agreement of
volumes measured with the Hexoskin shirt and (mobile) spirometer (gold
standard), the study will be terminated prematurely.
Study burden and risks
No potential risks of wearing the shirt are known and expected. There are no
potential risks mentioned or found in studies involving The Hexoskin shirt.
Subjects in both groups do not benefit from participation. If unexpected
findings exist, in the standard lung function examinations, the subject and his
or her general practitioner/ treating specialist will be informed on these
results.
Geert Grooteplein 10
Nijmegen 6525 GA
NL
Geert Grooteplein 10
Nijmegen 6525 GA
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL65299.044.18 |