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Набор скоро начнётся NCT07701096

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

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

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Home NPPV.
Кому может быть актуально
Состояния в реестре: Pulmonary Disease, Chronic Obstructive (COPD), Chronic Respiratory Failure With Hypercapnia, Noninvasive Ventilation. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Вмешательства

  • Устройство 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.

Первичные конечные точки

  • One-year hospitalization rate due to acute exacerbation of COPD [Срок оценки: 12 months]
Вторичные конечные точки (6)
  • Number of COPD-related hospitalizations [Срок оценки: 12 months]
  • Number of acute exacerbations of COPD [Срок оценки: 12 months]
  • Emergency department visit rate due to acute exacerbation of COPD [Срок оценки: 12 months]
  • Intensive care unit admission rate due to acute exacerbation of COPD [Срок оценки: 12 months]
  • Invasive mechanical ventilation rate due to acute exacerbation of COPD [Срок оценки: 12 months]
  • One-year all-cause mortality [Срок оценки: 12 months]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07701096 · BeijingCYH-RESET-COPD Cohort

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗