About this trial
This study aims to evaluate the impact of long-term home non-invasive ventilation (NIV) on patients with COPD
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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).
Trial design
Parallel
Treatments tested in this trial
BiPAP device (non invasive ventilation)
DeviceBiPAP 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
Optimal Medical Management ( long acting beta agonist , long acting muscarinic antagonist and inhaled corticosteroids)
DrugPatients will continue on standard COPD management: inhaled bronchodilators, inhaled corticosteroids, LTOT when required, but without NIV
Treatment groups
Trial outcomes
Primary outcomes
Changes in arterial blood gas parameter "PaCO₂"
follow up PaCo2 level measured by mmhg
Assessment of Adherence to BiPAP therapy
measured as the average hours of nightly use
Secondary outcomes
Improvements in quality of life
Measured using the validated St. George's Respiratory Questionnaire - COPD. Scale range: 0-100 (0 = no impairment, 100 = maximum impairment). Direction: Higher scores indicate worse quality of life.
Improvement in Dyspnea
Measured using the Modified Medical Research Council (mMRC) Dyspnea Scale. Scale range: 0-4 (0 = no breathlessness, 4 = severe breathlessness). Direction: Higher scores indicate worse dyspnea.
Improvement in COPD-Related Symptoms
Measured using the COPD Assessment Test (CAT). Scale range: 0-40 (0 = no symptoms, 40 = very severe symptoms). Direction: Higher scores indicate more severe symptoms and worse impact on daily life.
Total Duration of COPD-Related Hospitalization per Year
Documented as the cumulative number of days spent in hospital for COPD exacerbations during the study period. Unit of Measure: Days hospitalized per participant per year
Locations
Sponsors and contacts
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