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
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
Remote Management
Other interventionParticipants will receive home non-invasive respiratory support combined with active remote management. This includes regular analysis of ventilation data, assessment of oxygenation status, risk prediction, and remote parameter adjustment by a respiratory therapist.
Remote Monitoring Only
Other interventionParticipants will receive home non-invasive respiratory support with remote monitoring only. No active intervention will be performed by the study team based on the data. Patients will continue with standard care from their primary physician.
Treatment groups
Trial outcomes
Primary outcomes
Change in Health-Related Quality of Life
Measured by the change from baseline in the total score of the St. George's Respiratory Questionnaire (SGRQ) questionnaire at 12 months.
Number of COPD Exacerbations
The number of acute exacerbations requiring antibiotics and/or systemic corticosteroids within 12 months.
Secondary outcomes
Change in PaCO₂
The change from baseline in arterial partial pressure of carbon dioxide (PaCO₂) at 1, 3, 6, and 12 months.
Changes in PaO₂
The change from baseline in arterial partial pressure of oxygen (PaO₂) at 1, 3, 6, and 12 months.
Change in Dyspnea Severity (mMRC Score)
The change from baseline in the modified Medical Research Council (mMRC) dyspnea scale score to each follow up. The scale ranges from 0 to 4, with higher scores indicating more severe dyspnea.
Change in CAT Score
The change from baseline in the total score of the COPD Assessment Test (CAT) at 1, 3, 6, and 12 months.
Sponsors and contacts
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