About this trial
This study is a randomized controlled trial designed to compare the effectiveness of active remote intervention versus passive monitoring alone in patients with Chronic Obstructive Pulmonary Disease (COPD) and chronic hypercapnic respiratory failure who are receiving home non-invasive respiratory support. The primary goal is to evaluate the impact on health-related quality of life and the frequency of acute exacerbations over a 12-month period.
Eligibility criteria
Qualifiers
Meets the diagnostic criteria for Chronic Obstructive Pulmonary Disease (COPD) with confirmed persistent airflow limitation by spirometry.
Hospitalized due to an acute exacerbation of COPD.
Stable daytime arterial blood gas analysis showing PaCO₂ ≥ 50 mmHg, with hypoxemia.
Already receiving or planned to receive long-term home non-invasive respiratory support.
Disqualifiers
Concurrent severe pulmonary diseases (e.g., active tuberculosis, diffuse pulmonary fibrosis, advanced lung cancer).
Chronic respiratory failure primarily caused by non-COPD conditions (e.g., neuromuscular disease, chest wall deformity, or severe obesity hypoventilation syndrome).
Severe cognitive impairment or psychiatric illness that would prevent cooperation with remote management.
Other severe systemic diseases with an expected survival of less than 1 year (e.g., advanced malignancy).
Trial design
Treatments tested in this trial
- Remote Management
- Remote Monitoring Only