This study aims to evaluate the impact of long-term home non-invasive ventilation (NIV) on patients with COPD
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
40
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
Patients will continue on standard COPD management: inhaled bronchodilators, inhaled corticosteroids, LTOT when required, but without NIV
Changes in arterial blood gas parameter "PaCO₂"
follow up PaCo2 level measured by mmhg
Time frame: 1 year
Assessment of Adherence to BiPAP therapy
measured as the average hours of nightly use
Time frame: 1 year
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.
Time frame: 1 year
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.
Time frame: 1 year
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.
Time frame: 1 year
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
Time frame: 1 year
Number of COPD-Related Hospitalizations per Year
Documented as the total number of hospital admissions for COPD exacerbations during the study period. Unit of Measure: Number of hospitalizations per participant per year
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Time frame: 1 year
Assessment of Overall survival
Assessment of Overall survival between 2 cohorts (one year mortality)
Time frame: 1 year