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Not yet recruiting NCT07701096

RESET-COPD Cohort: Real-Time Monitoring and Early Warning in COPD Patients Receiving Home NPPV

— Observational Pulmonary Disease, Chronic Obstructive (COPD) Chronic Respiratory Failure With Hypercapnia Noninvasive Ventilation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Home NPPV.
Who it may be relevant to
Registry conditions: Pulmonary Disease, Chronic Obstructive (COPD), Chronic Respiratory Failure With Hypercapnia, Noninvasive Ventilation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Multicenter Prospective Cohort Study for Real-Time Monitoring and Intelligent Early Warning Model Development in COPD Patients Receiving Home Noninvasive Positive Pressure Ventilation

Overview

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.

Interventions

  • Device Home NPPV
    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.

Primary outcome measures

  • One-year hospitalization rate due to acute exacerbation of COPD [Time frame: 12 months]
Secondary outcome measures (6)
  • Number of COPD-related hospitalizations [Time frame: 12 months]
  • Number of acute exacerbations of COPD [Time frame: 12 months]
  • Emergency department visit rate due to acute exacerbation of COPD [Time frame: 12 months]
  • Intensive care unit admission rate due to acute exacerbation of COPD [Time frame: 12 months]
  • Invasive mechanical ventilation rate due to acute exacerbation of COPD [Time frame: 12 months]
  • One-year all-cause mortality [Time frame: 12 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07701096 · BeijingCYH-RESET-COPD Cohort

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗