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Набор скоро начнётся NCT07198880

Impact of Home Non Invasive Ventilation in Patients With Chronic Obstructive Pulmonary Disease Discharged From Assiut University Hospital

Без фазы С лечением COPD COPD (Chronic Obstructive Pulmonary Disease) Ventilation Therapy Non Invasive Ventilation (NIV)

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: BiPAP device (non invasive ventilation), Optimal Medical Management ( long acting beta agonist , long acting muscarinic antagonist and inhaled corticosteroids).
Кому может быть актуально
Состояния в реестре: COPD, COPD (Chronic Obstructive Pulmonary Disease), Ventilation Therapy, Non Invasive Ventilation (NIV). Базовые параметры: 18 лет — 80 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
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Обзор

This study aims to evaluate the impact of long-term home non-invasive ventilation (NIV) on patients with COPD

Подробное описание

Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality worldwide . A subset of patients develops chronic hypercapnia, which is linked to frequent hospitalizations, reduced quality of life, and poor survival. Despite optimized pharmacological therapy, pulmonary rehabilitation, and long-term oxygen therapy (LTOT), outcomes in these patients remain unsatisfactory.

Early randomized trials failed to show survival benefit from home Non Invasive Ventilation , largely due to low ventilatory pressures, poor adherence, and heterogeneous patient selection . More recent studies suggest a positive impact and demonstrated improved long-term survival, some studies reported reduced mortality with high-intensity NIV targeting PaCO₂ reduction .

Meta-analyses indicate that patients with persistent hypercapnia after an acute exacerbation are most likely to benefit , though uncertainties remain regarding patient selection and long-term real-world outcomes.

Management of chronic hypercapnic COPD currently includes pharmacological treatment, LTOT, and rehabilitation.

NIV is a cornerstone in acute exacerbations, but its role in the chronic setting is not universally established, and routine use in home care is limited.

Вмешательства

  • Устройство BiPAP device (non invasive ventilation)
    BiPAP initiated 2-4 weeks post-discharge; IPAP 16 cmH₂O (titrate), EPAP 4 cmH₂O; supplemental O₂ as needed monitor SpO₂, ABG, vitals; target ≥20% PaCO₂ reduction, improved pH, reduced work of breathing; adherence ≥4 hrs/nigh Scheduled monitoring of SpO₂, symptoms, and adherence; outpatient follow-up at 2-4 weeks and after 1, 3, 6 ,12 month intervals
  • Препарат Optimal Medical Management ( long acting beta agonist , long acting muscarinic antagonist and inhaled corticosteroids)
    Patients will continue on standard COPD management: inhaled bronchodilators, inhaled corticosteroids, LTOT when required, but without NIV

Первичные конечные точки

  • Changes in arterial blood gas parameter "PaCO₂" [Срок оценки: 1 year]
  • Assessment of Adherence to BiPAP therapy [Срок оценки: 1 year]
Вторичные конечные точки (6)
  • Improvements in quality of life [Срок оценки: 1 year]
  • Improvement in Dyspnea [Срок оценки: 1 year]
  • Improvement in COPD-Related Symptoms [Срок оценки: 1 year]
  • Total Duration of COPD-Related Hospitalization per Year [Срок оценки: 1 year]
  • Number of COPD-Related Hospitalizations per Year [Срок оценки: 1 year]
  • Assessment of Overall survival [Срок оценки: 1 year]

Критерии участия

Критерии включения

  • Patients more than 18 year old.
  • Severe COPD (classified as GOLD stage Ⅲ and IV), confirmed by FEV₁/FVC < 70% and FEV₁ < 50% of the predicted value. (9)
  • Persistent hypercapnia (PaCO₂ ≥ 60 mmHg ≥2 weeks after resolution of acute exacerbation and compliant on optimal medical therapy with or without long term oxygen therapy

Критерии исключения

  • Other significant respiratory disorders (e.g,history suggestive OSA, Body Mass Index more than 30, pneumothorax, bullous lung disease, advanced interstitial lung diseases , restrictive thoracic wall diseases , neuromuscular disease).
  • Undergone intubation or tracheostomy prior to NIV initiation during the last 2 months.
  • Those using addictive narcotic medications.
  • Comorbidities and diseases that might confound survival outcomes (e.g., malignancy, advanced hepatic or renal diseases).
  • Pregnancy
  • Refusal or Inability to tolerate NIV during initiation and adaptation phase.
  • Expected Poor compliance (patients deemed unlikely to adhere to nightly NIV use such as no family support, severe frailty).
  • Withdrawal criteria: stopping bipap or medical treatment, voluntary withdrawal by the participant, failure to attend scheduled visits, and significant clinical deterioration requiring alternative management during the study period

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07198880 · NIV in COPD Patients

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗