RESET-COPD Cohort: Real-Time Monitoring and Early Warning in COPD Patients Receiving Home NPPV (RESET-COPD)
A Multicenter Prospective Cohort Study for Real-Time Monitoring and Intelligent Early Warning Model Development in COPD Patients Receiving Home Noninvasive Positive Pressure Ventilation
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- Age 18 years or older.
- Diagnosis of COPD according to GOLD 2026 criteria, with post-bronchodilator FEV1/FVC < 0.70.
- Severe airflow limitation, defined as FEV1 < 50% of predicted value, corresponding to GOLD grade III-IV.
- Chronic hypercapnic respiratory failure, defined as arterial PaCO₂ ≥ 53 mmHg or ≥ 7.0 kPa while breathing room air in a clinically stable state, that is, no acute exacerbation of COPD within at least 4 weeks before enrollment.
Exclusion Criteria:
- Chronic respiratory failure caused by diseases other than COPD, including neuromuscular diseases, chest wall deformity, obstructive sleep apnea, or severe obesity with BMI > 35 kg/m².
- Severe cardiovascular disease, including NYHA class IV heart failure or unstable angina.
- Severe renal disease receiving long-term renal replacement therapy.
- Expected survival of less than 1 year, including active malignancy or end-stage systemic disease.
- Inability to complete the study, including cognitive impairment, psychiatric disease, inability to cooperate with NPPV, inability to use wearable devices, or inability to complete follow-up.
- Refusal to participate in the study or refusal to sign informed consent.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
One-year hospitalization rate due to acute exacerbation of COPD
Tijdsspanne: 12 months
|
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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Number of COPD-related hospitalizations
Tijdsspanne: 12 months
|
Number of hospitalizations related to acute exacerbation of COPD during follow-up.
|
12 months
|
|
Number of acute exacerbations of COPD
Tijdsspanne: 12 months
|
The total number of hospitalizations due to clinically confirmed acute exacerbation of COPD during the 12-month follow-up period.
|
12 months
|
|
Emergency department visit rate due to acute exacerbation of COPD
Tijdsspanne: 12 months
|
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
Tijdsspanne: 12 months
|
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
Tijdsspanne: 12 months
|
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
Tijdsspanne: 12 months
|
The proportion of participants who die from any cause during the 12-month follow-up period.
|
12 months
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- BeijingCYH-RESET-COPD Cohort
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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