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NCT Number: NCT07198880

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

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. Changes in arterial blood gas parameter "PaCO₂"

    Time frame: 1 year

    follow up PaCo2 level measured by mmhg

  2. Assessment of Adherence to BiPAP therapy

    Time frame: 1 year

    measured as the average hours of nightly use

Secondary outcomes

  1. Improvements in quality of life

    Time frame: 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.

  2. Improvement in Dyspnea

    Time frame: 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.

  3. Improvement in COPD-Related Symptoms

    Time frame: 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.

  4. Total Duration of COPD-Related Hospitalization per Year

    Time frame: 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

  5. Number of COPD-Related Hospitalizations per Year

    Time frame: 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

  6. Assessment of Overall survival

    Time frame: 1 year

    Assessment of Overall survival between 2 cohorts (one year mortality)

Study contacts

Contact information is provided by the study sponsor or research team.

Mostafa Mahmoud Ahmed

CONTACT

[email protected]

0201001554241

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 30, 2025
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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