NCT07198880

Impact of Home Non Invasive Ventilation in Patients With Chronic Obstructive Pulmonary Disease Discharged From Assiut University Hospital

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COPD
• COPD (Chronic Obstructive Pulmonary Disease)
• Ventilation Therapy
• Non Invasive Ventilation (NIV)
• BiPAP
• Hypercapnia
• Long Term Oxygen Therapy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-01-01
• Primary completion: 2027-01-01
• Completion: 2028-01-01
• First posted: 2025-09-30
• Last updated: 2025-09-30