Impact of Home Non Invasive Ventilation in Patients With Chronic Obstructive Pulmonary Disease Discharged From Assiut University Hospital
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Changes in arterial blood gas parameter "PaCO₂"
研究概览
简要总结
This study aims to evaluate the impact of long-term home non-invasive ventilation (NIV) on patients with COPD
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
NIV Group
Patients who can afford to buy or attain a Bi-PAP device will be enrolled in this interventional group long-term NIV (Bi-PAP), They will also keep taking their optimal medical therapy, with or without LTOT according to oxygen status.
干预措施: BiPAP device (non invasive ventilation) (Device)
NIV Group
Patients who can afford to buy or attain a Bi-PAP device will be enrolled in this interventional group long-term NIV (Bi-PAP), They will also keep taking their optimal medical therapy, with or without LTOT according to oxygen status.
干预措施: Optimal Medical Management ( long acting beta agonist , long acting muscarinic antagonist and inhaled corticosteroids) (Drug)
Control Group
Patients who cannot attain a BiPAP device are managed with their optimal medical therapy, with or without LTOT according to oxygen status
干预措施: Optimal Medical Management ( long acting beta agonist , long acting muscarinic antagonist and inhaled corticosteroids) (Drug)
结局指标
主要结局
Changes in arterial blood gas parameter "PaCO₂"
时间窗: 1 year
follow up PaCo2 level measured by mmhg
Assessment of Adherence to BiPAP therapy
时间窗: 1 year
measured as the average hours of nightly use
次要结局
- Improvements in quality of life(1 year)
- Improvement in Dyspnea(1 year)
- Improvement in COPD-Related Symptoms(1 year)
- Total Duration of COPD-Related Hospitalization per Year(1 year)
- Number of COPD-Related Hospitalizations per Year(1 year)
- Assessment of Overall survival(1 year)
研究者
Mostafa Mahmoud Ahmed AbdAllah
Principal investigator
Assiut University