No registrations found.
ID
Source
Brief title
Health condition
dynamic hyperinflation; COPD; Hexoskin; dyspnea ; dyspneu;metronome - paced tachypnea ; hyperinflatie
Sponsors and support
Intervention
Outcome measures
Primary outcome
Correlation between the lung function equipment and the Hexoskin smart shirt for the detection of dynamic hyperinflation in patients with COPD.
Secondary outcome
The degree of dynamic hyperinflation
- Cohen's kappa to assess the level of agreement between the two used methods.
- Linear regression to describe the correlation
- Sensitivity and specificity in the detection of dynamic hyperinflation under the assumption that lung function equipment serves as gold standard.
- Bland Altman analyssis
- User experience of the smart shirt
Background summary
In this study the Hexoskin smart shirt is tested for its applicability to detect and quantify dynamic hyperinflation in COPD patients. First a group of healthy volunteers will be measured, followed by a group of patients to test the accuracy of the shirt for the detection of dynamic hyperinflation.
Study objective
The hypothesis is that the Hexoskin smart shirt is able to detect dynamic hyperinflation in COPD patients, based on the respiratory inductance plethysmography technique incorporated in the shirt.
Study design
A single visit to the hospital for participation in the study.
Intervention
No intervention, just monitoring of the vital parameters with the Hexoskin smart shirt.
Department of Pulmonology<br>
PO Box 50.000
P.D.L.P.M. Valk, van der
Enschede 7500 KA
The Netherlands
+31 (0)53 4872610
P.vanderValk@mst.nl
Department of Pulmonology<br>
PO Box 50.000
P.D.L.P.M. Valk, van der
Enschede 7500 KA
The Netherlands
+31 (0)53 4872610
P.vanderValk@mst.nl
Inclusion criteria
Phase 1:
- Healthy adult control subjects
Phase 2:
- Patients with COPD GOLD II-IV
- Patients with a high likelihood of experiencing dynamic hyperinflation, based on the expert's opinion and clinical parameters such as residual volume and a barrel shaped thorax.
- Patients that receive planned lung function tests, including spirometry and exercise testing.
- Patients with pulmonary problems, other than COPD, are incorporated in the control group of phase 2.
Exclusion criteria
- Inability to fit the available shirts
- Physical impairments preventing the execution of a physical task
- inability to read, speak or understand Dutch
- Subjects with a pacemaker or ICD device
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5485 |
| NTR-old | NTR5620 |
| CCMO | NL56190.044.15 |
| OMON | NL-OMON43533 |