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

Assiut University

Status: Not yet enrolling

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

Treatments: Device: BiPAP device (non invasive ventilation); Drug: Optimal Medical Management ( long acting beta agonist , long acting muscarinic antagonist and inhaled corticosteroids)

Study type: Interventional

Funder types: Other

Identifiers

NCT07198880

NIV in COPD Patients

Details and patient eligibility

About

This study aims to evaluate the impact of long-term home non-invasive ventilation (NIV) on patients with COPD

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

NIV Group

Experimental group

Description:

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.

Treatment:

Drug: Optimal Medical Management ( long acting beta agonist , long acting muscarinic antagonist and inhaled corticosteroids)

Device: BiPAP device (non invasive ventilation)

Control Group

Active Comparator group

Description:

Patients who cannot attain a BiPAP device are managed with their optimal medical therapy, with or without LTOT according to oxygen status

Treatment:

Drug: Optimal Medical Management ( long acting beta agonist , long acting muscarinic antagonist and inhaled corticosteroids)