NOT YET RECRUITING
NCT07701096
RESET-COPD Cohort: Real-Time Monitoring and Early Warning in COPD Patients Receiving Home NPPV
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.
Gender: All
Ages: 18 Years - Any
Pulmonary Disease, Chronic Obstructive (COPD)
Chronic Respiratory Failure With Hypercapnia
Noninvasive Ventilation