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This is a multicenter prospective cohort study designed to develop and validate a multisensor-based real-time monitoring and intelligent early warning model for acute exacerbations in patients with chronic obstructive pulmonary disease receiving home noninvasive positive pressure ventilation.
Eligible participants will be adults with severe COPD and chronic hypercapnic respiratory failure who are receiving or newly initiating home noninvasive positive pressure ventilation. Participants will undergo baseline assessment and follow-up visits at 3, 6, and 12 months. Clinical data, arterial blood gas measurements, pulmonary function, exercise capacity, symptom burden, health-related quality of life, psychological status, home noninvasive ventilation parameters, adherence, device-related adverse events, healthcare utilization, acute exacerbations, hospitalizations, intensive care unit admissions, invasive mechanical ventilation, and mortality will be collected.
Continuous physiological monitoring data, will be used to construct individualized stable baseline values and to identify digital warning signals. Digital warning events will be further adjudicated through symptom confirmation, treatment and healthcare utilization verification, exclusion of alternative explanations, and investigator assessment.
The study aims to establish a longitudinal clinical and physiological dataset for COPD patients receiving home noninvasive ventilation and to evaluate the performance of a multisensor-based early warning model for clinically confirmed acute exacerbations of COPD.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home NPPV | Device | Home noninvasive positive pressure ventilation is used as part of routine clinical care in patients with severe COPD and chronic hypercapnic respiratory failure. Ventilator mode, pressure settings, oxygen supplementation, adherence, tolerance, complications, and device safety will be prospectively recorded during follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| One-year hospitalization rate due to acute exacerbation of COPD | The proportion of participants who experience at least one hospitalization due to clinically confirmed acute exacerbation of COPD during the 12-month follow-up period. Hospitalization due to acute exacerbation of COPD will be confirmed based on symptom worsening, treatment or healthcare utilization, exclusion of alternative explanations, and investigator adjudication. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of COPD-related hospitalizations | Number of hospitalizations related to acute exacerbation of COPD during follow-up. | 12 months |
| Number of acute exacerbations of COPD | The total number of hospitalizations due to clinically confirmed acute exacerbation of COPD during the 12-month follow-up period. |
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Inclusion Criteria:
Exclusion Criteria:
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Study participants will be selected from adult patients with severe chronic obstructive pulmonary disease and chronic hypercapnic respiratory failure who are managed at participating clinical centers and who are receiving or newly initiating home noninvasive positive pressure ventilation. The study population will include clinically stable COPD patients with severe airflow limitation and persistent hypercapnia who are suitable for home NPPV follow-up and multisensor real-time monitoring.
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| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
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| 12 months |
| Emergency department visit rate due to acute exacerbation of COPD | The proportion of participants with at least one emergency department visit due to clinically confirmed acute exacerbation of COPD during the 12-month follow-up period. | 12 months |
| Intensive care unit admission rate due to acute exacerbation of COPD | The proportion of participants with at least one intensive care unit admission due to clinically confirmed acute exacerbation of COPD during the 12-month follow-up period. | 12 months |
| Invasive mechanical ventilation rate due to acute exacerbation of COPD | The proportion of participants who receive invasive mechanical ventilation due to clinically confirmed acute exacerbation of COPD during the 12-month follow-up period. | 12 months |
| One-year all-cause mortality | The proportion of participants who die from any cause during the 12-month follow-up period. | 12 months |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |