RECRUITINGINTERVENTIONAL

Multiparametric Home Telemonitoring of Patients With Chronic Obstructive Pulmonary Disease Exacerbation

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: 1. Able to understand and sign the willing to sign a consent form form. 2. Already established diagnosis of COPD according to Global Initiative for Obstructive Lung Disease (GOLD) guidelines.\[13\] 3. Diagnosis of COPD exacerbation at admission, according to GOLD guidelines.\[13\] 4. 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. 5. 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. Who Should NOT Join This Trial: 1. Heart failure as the main cause of acute respiratory failure 2. Acute pulmonary embolism/chronic pulmonary thromboembolism 3. Interstitial lung disease as the main cause of acute respiratory failure 4. Pneumonia as the main cause of acute respiratory failure 5. Chronic renal failure with dialysis dependence 6. Immunosuppression (i.e. cancer on treatment, post-organ transplantation, HIV-positive, on immunosuppressant therapy) 7. Progressive neuro-muscular disorders 8. Cognitively impaired, dementia or decompensated psychiatric disorder 9. Quadriplegia/Hemiplegia or quadriparesis/hemiparesis 10. Do-not-resuscitate order 11. Any other condition that in the opinion of the investigator may significantly impact with patient's capability to comply with the protocol Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Able to understand and sign the informed consent form. 2. Already established diagnosis of COPD according to Global Initiative for Obstructive Lung Disease (GOLD) guidelines.\[13\] 3. Diagnosis of COPD exacerbation at admission, according to GOLD guidelines.\[13\] 4. 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. 5. 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: 1. Heart failure as the main cause of acute respiratory failure 2. Acute pulmonary embolism/chronic pulmonary thromboembolism 3. Interstitial lung disease as the main cause of acute respiratory failure 4. Pneumonia as the main cause of acute respiratory failure 5. Chronic renal failure with dialysis dependence 6. Immunosuppression (i.e. cancer on treatment, post-organ transplantation, HIV-positive, on immunosuppressant therapy) 7. Progressive neuro-muscular disorders 8. Cognitively impaired, dementia or decompensated psychiatric disorder 9. Quadriplegia/Hemiplegia or quadriparesis/hemiparesis 10. Do-not-resuscitate order 11. Any other condition that in the opinion of the investigator may significantly impact with patient's capability to comply with the protocol

Treatments Being Tested

DEVICE

Telemonitoring

Patients will be asked to carry out one measurement (arterial pressure, oxygen saturation, body temperature, heart rate, spirometry) every 24 hours for 90 days. The system will be supplied by the company Vivisol. The telemonitoring data will be read once a day and the principal investigator will be alerted in case of alteration of any parameter. If vital parameters remain stable, a phone call will be performed every 5 days. In case of compromise of any parameter, the patient will be offered a phone call within the same day. In case of new occurrence of any respiratory or non-respiratory symptoms, the patient must contact the principal investigator and he will be offered a phone call or a video-assisted call within the same day. If the alterations or symptoms persist for 24 hours, or in any case upon decision of the investigator in charge, the patient will be offered an in-person evaluation in the same day. If deemed necessary according to usual care, the patient will be hospitalized.

Locations (1)

SC Pneumologia, Azienda Sanitaria Universitaria Giuliano-Isontina

Trieste, Italy