BiPAP, COPD, COPD (Chronic Obstructive Pulmonary Disease), Hypercapnia, Long Term Oxygen Therapy, Non Invasive Ventilation (NIV), Ventilation Therapy
Conditions
Brief summary
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
DEVICEBiPAP 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
DRUGOptimal 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
Sponsors
Assiut University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in arterial blood gas parameter PaCO₂ | 1 year | follow up PaCo2 level measured by mmhg |
| Assessment of Adherence to BiPAP therapy | 1 year | measured as the average hours of nightly use |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in COPD-Related Symptoms | 1 year | 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 | 1 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 |
| Improvements in quality of life | 1 year | 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. |
| Assessment of Overall survival | 1 year | Assessment of Overall survival between 2 cohorts (one year mortality) |
| Number of COPD-Related Hospitalizations per Year | 1 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 |
| Improvement in Dyspnea | 1 year | 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. |
Contacts
Primary ContactMostafa Mahmoud Ahmed
Outcome results
None listed