Real-time monitoring and early warning for COPD patients on home NIV

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter prospective cohort aims to develop and validate an intelligent early warning model using continuous physiological data for COPD patients with chronic hypercapnic respiratory failure on home NIV. Participants will have baseline assessments and follow-up visits at 3, 6, and 12 months, with data collected on lung function, gas exchange, symptoms, quality of life, NIV settings, adherence, adverse events, and healthcare utilization. The study is observational and focuses on model development and validation rather than an intervention. Eligible adults have severe COPD (GOLD 2026 criteria, post-bronchodilator FEV1/FVC < 0.70, FEV1 < 50%), chronic hypercapnia (PaCO2 ≥ 52 mmHg) in a stable state. Exclusion criteria include non-COPD causes of respiratory failure, severe cardiovascular or renal disease, and limited life expectancy.</0>

Why it matters

Who can join: the full rules

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 hypercapnia, defined as arterial PaCO₂ ≥ 52 mmHg (approximately 7.0 kPa) in a clinically stable state (no acute exacerbation of COPD within at least 4 weeks before enrollment), with arterial blood gas analysis performed in the sitting position at rest and after discontinuation of NPPV for at least 2 hours.

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.

Where it's running

• Beijing Chao-Yang Hospital, Capital Medical University
  Beijing, China Recruiting

Study contacts

• Study coordinator: Zujin Luo, MD
• Email: xmjg2002@163.com
• Phone: +86-13810497587

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.