Status:
NOT_YET_RECRUITING
Impact of Home Non Invasive Ventilation in Patients With Chronic Obstructive Pulmonary Disease Discharged From Assiut University Hospital
Lead Sponsor:
Assiut University
Conditions:
COPD
COPD (Chronic Obstructive Pulmonary Disease)
Eligibility:
All Genders
18-80 years
Phase:
NA
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, re...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT07198880
Start Date
January 1 2026
End Date
January 1 2028
Last Update
September 30 2025
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