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


- candidate number23649
- NTR NumberNTR5620
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-jan-2016
- Secondary IDsNL56190.040.15 
- Public TitleContinous monitoring of ventilation with the Hexoskin smart shirt to detect dynamic hyperinflation in COPD patients.
- Scientific TitleContinous monitoring of ventilation with the Hexoskin smart shirt to detect dynamic hyperinflation in COPD patients.
- ACRONYMCHOPIN
- hypothesisThe 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.
- Healt Condition(s) or Problem(s) studiedCOPD
- Inclusion criteriaPhase 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
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-mrt-2016
- planned closingdate1-sep-2016
- Target number of participants45
- InterventionsNo intervention, just monitoring of the vital parameters with the Hexoskin smart shirt.
- Primary outcomeCorrelation between the lung function equipment and the Hexoskin smart shirt for the detection of dynamic hyperinflation in patients with COPD.
- Secondary outcomeThe 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
- TimepointsA single visit to the hospital for participation in the study.
- Trial web sitenot applicable
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. P.D.L.P.M. Valk, van der
- CONTACT for SCIENTIFIC QUERIESDr. P.D.L.P.M. Valk, van der
- Sponsor/Initiator Medisch Spectrum Twente
- Funding
(Source(s) of Monetary or Material Support)
University of Twente
- Publications
- Brief summaryIn 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.
- Main changes (audit trail)
- RECORD25-jan-2016 - 15-apr-2016


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