Chronic Obstructive Pulmonary Disease (COPD) Monitoring

Medtronic

Status

Unknown

Conditions

COPD

COPD Exacerbation

Treatments

Other: exercises

Study type

Interventional

Funder types

Industry

Identifiers

NCT04671888

MDT19035

Details and patient eligibility

About

The present feasibility study aims at assessing whether the EMG of respiratory muscles can serve as an objective marker of dyspnea in COPD patients.

The study aims also at evaluating the changes in physiological parameters (i.e., EMG, respiration rate, heart rate, temperature, and SpO2) occurring when simulating daily activities before, during and after acute exacerbations. All this information can be useful to detect the exacerbations earlier or to provide better treatment during the exacerbations.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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