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Continous monitoring of ventilation with the Hexoskin smart shirt to detect dynamic hyperinflation in COPD patients.

Continous monitoring of ventilation with the Hexoskin smart shirt to detect dynamic hyperinflation in COPD patients.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON21984
Enrollment
45
Registered
2016-01-25
Start date
2016-03-01
Completion date
Unknown
Last updated
2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

dynamic hyperinflation

Interventions

No intervention, just monitoring of the vital parameters with the Hexoskin smart shirt.

Sponsors

Medisch Spectrum Twente, Enschede
Lead Sponsor

Eligibility

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
Correlation between the lung function equipment and the Hexoskin smart shirt for the detection of dynamic hyperinflation in patients with COPD.

Secondary

MeasureTime frame
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

Contacts

Public ContactP.D.L.P.M. Valk, van der

Medisch Spectrum Twente Hospital Department of Pulmonology PO Box 50.000

P.vanderValk@mst.nl+31 (0)53 4872610

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)