Multiparametric Home Telemonitoring of Patients With Chronic Obstructive Pulmonary Disease Exacerbation

Recruiting now · Not applicable

Conditions studied: COPD, COPD Exacerbation Acute

In brief

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.

Key facts

Study ID

NCT06331416

Run by

University of Trieste

People needed

60

Starts

2024-03-29

Expected to finish

2026-09-30

Last updated by the study team

2024-05-02

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

• SC Pneumologia, Azienda Sanitaria Universitaria Giuliano-Isontina — Trieste, Italy (enrolling)

Full record on ClinicalTrials.gov

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