Impact of Home Non Invasive Ventilation in Patients With Chronic Obstructive Pulmonary Disease Discharged From Assiut University Hospital
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: BiPAP device (non invasive ventilation), Optimal Medical Management ( long acting beta agonist , long acting muscarinic antagonist and inhaled corticosteroids).
- Who it may be relevant to
- Registry conditions: COPD, COPD (Chronic Obstructive Pulmonary Disease), Ventilation Therapy, Non Invasive Ventilation (NIV). Basic parameters: 18 years — 80 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 →
Overview
This study aims to evaluate the impact of long-term home non-invasive ventilation (NIV) on patients with COPD
Detailed description
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.
Interventions
- Device 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 - Drug 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
Primary outcome measures
- Changes in arterial blood gas parameter "PaCO₂" [Time frame: 1 year]
- Assessment of Adherence to BiPAP therapy [Time frame: 1 year]
Secondary outcome measures (6)
- Improvements in quality of life [Time frame: 1 year]
- Improvement in Dyspnea [Time frame: 1 year]
- Improvement in COPD-Related Symptoms [Time frame: 1 year]
- Total Duration of COPD-Related Hospitalization per Year [Time frame: 1 year]
- Number of COPD-Related Hospitalizations per Year [Time frame: 1 year]
- Assessment of Overall survival [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07198880 · NIV in COPD Patients