NCT06331416 Multiparametric Home Telemonitoring of Patients With Chronic Obstructive Pulmonary Disease Exacerbation
| NCT ID | NCT06331416 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Trieste |
| Condition | COPD |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-03-29 |
| Primary Completion | 2026-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-03-29 with a primary completion date of 2026-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Marco Confalonieri, MD
STUDY CHAIR
University of Trieste
Frequently Asked Questions
Who can join the NCT06331416 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying COPD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06331416 currently recruiting?
Yes, NCT06331416 is actively recruiting participants. Contact the research team at francesco.salton@gmail.com for enrollment information.
Where is the NCT06331416 trial being conducted?
This trial is being conducted at Trieste, Italy.
Who is sponsoring the NCT06331416 clinical trial?
NCT06331416 is sponsored by University of Trieste. The principal investigator is Marco Confalonieri, MD at University of Trieste. The trial plans to enroll 60 participants.
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