Chronic Obstructive Pulmonary Disease (COPD) Monitoring

Launched by MEDTRONIC BRC · Dec 11, 2020

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subject must have a clinical diagnosis of COPD
• • mMRC (Modified Medical Research Council) Dyspnea Scale Score \> 1
• • Subject must be indicated for regular inpatient pulmonary rehabilitation
• • Subject must be hyperinflated, defined as residual volume (RV)\>120% of the predicted value, measured by whole body plethysmography
• • Subject must be willing to provide Informed Consent for their participation in the study
• • Subject must be ≥18 years of age
• Exclusion Criteria:
• • Subjects who are unable/unwilling to voluntarily participate in the study
• • Subjects who cannot read/write
• • Subjects who are dependent on oxygen and/or unfit to wear a mask during sub- maximal constant work rate test (CWRT)
• • Subject has congenital heart disease
• • Subject has unstable coronary artery disease
• • Subject has an active implanted cardiac device (i.e. IPG, ICD)
• • Subject has heart failure NYHA 4
• • Subject presents any concomitant condition which in the opinion of the investigator would not allow a safe participation in the study
• • Subject is legally incompetent
• • Subject is pregnant or has suspect to be pregnant
• • Subject is enrolled in a concurrent study that may confound the results of this study without documented pre-approval from Medtronic study manager
• • BORG scale assessment is evaluated as unreliable due to patient's cognitive condition