Multiparametric Home Telemonitoring of Patients With Chronic Obstructive Pulmonary Disease Exacerbation
Recruiting · NCT06331416 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Trieste
View the official record on ClinicalTrials.gov →Interventions studied
Telemonitoring
What this trial is about
Chronic obstructive pulmonary disease (COPD) exacerbations are risk factors for disease progression and short-term re- hospitalizations. We propose a randomized controlled trial to evaluate the efficacy of a one-device multiparameter telemonitoring in reducing functional decline, symptoms, and risk of re-hospitalization of patients discharged after hospitalization for exacerbated COPD.
Who can take part
Age range
18 Years to 90 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Able to understand and sign the informed consent form.
- Already established diagnosis of COPD according to Global Initiative for Obstructive Lung Disease (GOLD) guidelines.\[13\]
- Diagnosis of COPD exacerbation at admission, according to GOLD guidelines.\[13\]
- Arterial partial pressure of oxygen (PaO2) \< 60 mmHg in ambient air at rest at admission and arterial partial pressure of oxygen (PaO2) \> 60 mmHg in ambient air at rest at discharge, if not on long-term oxygen therapy on ventilation.
- Arterial partial pressure of oxygen (PaO2) \< 55 mmHg on usual oxygen supplement (L/min) and arterial partial pressure of oxygen (PaO2) \> 60 mmHg on oxygen supplement at discharge, if already on long-term oxygen therapy on ventilation.
- g) Age \<= 90 and \>= 18 years old at randomization.
Exclusion criteria
- Heart failure as the main cause of acute respiratory failure
- Acute pulmonary embolism/chronic pulmonary thromboembolism
- Interstitial lung disease as the main cause of acute respiratory failure
- Pneumonia as the main cause of acute respiratory failure
- Chronic renal failure with dialysis dependence
- Immunosuppression (i.e. cancer on treatment, post-organ transplantation, HIV-positive, on immunosuppressant therapy)
- Progressive neuro-muscular disorders
- Cognitively impaired, dementia or decompensated psychiatric disorder
- Quadriplegia/Hemiplegia or quadriparesis/hemiparesis
- Do-not-resuscitate order
- Any other condition that in the opinion of the investigator may significantly impact with patient's capability to comply with the protocol
Where it is running
1 location listed.
- SC Pneumologia, Azienda Sanitaria Universitaria Giuliano-Isontina - Trieste, Italy