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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NIV Group | Experimental | 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. |
|
| Control Group | Active Comparator | Patients who cannot attain a BiPAP device are managed with their optimal medical therapy, with or without LTOT according to oxygen status |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BiPAP device (non invasive ventilation) | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in arterial blood gas parameter "PaCO₂" | follow up PaCo2 level measured by mmhg | 1 year |
| Assessment of Adherence to BiPAP therapy | measured as the average hours of nightly use | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
| Improvement in Dyspnea |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mostafa Mahmoud Ahmed | Contact | 0201001554241 | doc.mostafa5454@gmail.com |
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|
| Optimal Medical Management ( long acting beta agonist , long acting muscarinic antagonist and inhaled corticosteroids) | Drug | Patients will continue on standard COPD management: inhaled bronchodilators, inhaled corticosteroids, LTOT when required, but without NIV |
|
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. |
| 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. | 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 | 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 | 1 year |
| Assessment of Overall survival | Assessment of Overall survival between 2 cohorts (one year mortality) | 1 year |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D006935 | Hypercapnia |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D063087 | Noninvasive Ventilation |
| ID | Term |
|---|---|
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
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