Continuous monitoring of ventilation with the Hexoskin smart shirt to detect dynamic hyperinflation in COPD patients
- Conditions
- Dynamic hyperinflation (COPD)10038716
- Registration Number
- NL-OMON43533
- Lead Sponsor
- Medisch Spectrum Twente
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
Healthy subjects:
- Adult, volunteers;Patient group:
- Patients with COPD (GOLD I-IV) that receive planned pulmonary function testing including spirometry and a form of exercise testing (6 minute walk test and/or cardiopulmonary exercise test (CPET)).
- Patients with the clinical suspicion of hyperinflation based on the expert*s opinion. For example a barrel -shaped thorax or Hoover sign during physical examination, or a known increased resting volume (RV) present in spirometry data.;Control group:
- Patients who do not have a clinically defined COPD phenotype and do not have an outflow obstruction (No decrease in the Tiffenau index).
- Patients that receive the same planned pulmonary function tests as the patient group.
- An exacerbation of COPD with hospital admission in four weeks prior to inclusiondate.
- Other associated disease (heart, neurological, rheumatic, or orthopedic).
- Physical impairments causing any disability to perform a physical task
- Inability to read, understand or speak Dutch
- Subjects who do not fit into one of the available sensor shirts
- Subjects with a pacemaker / Implantable cardioverter-defibrillator (ICD) device
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main endpoint in this study is the Pearson correlation coefficient between<br /><br>the Hexoskin smart shirt and the standard devices to detect and quantify<br /><br>dynamic hyperinflation</p><br>
- Secondary Outcome Measures
Name Time Method <p>Furthermore the degree of dynamic hyperinflation that is detected with the<br /><br>Hexoskin smart shirt expressed either in milliliters or in arbitrary units<br /><br>is determined. Other outcome parameters are the sensitivity and specificity to<br /><br>detect dynamic hyperinflation and the usability of the shirt. A possible<br /><br>correlation between Borg dyspnea scores and the occurence of dynamic<br /><br>hyperinflation will be assessed as well.</p><br>