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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorAssiut University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: NIV GroupExperimental treatment 2 interventions
Group B: Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Changes in arterial blood gas parameter "PaCO₂"

follow up PaCo2 level measured by mmhg

Time frame
1 year
2

Assessment of Adherence to BiPAP therapy

measured as the average hours of nightly use

Time frame
1 year

Secondary outcomes

1

Improvements in quality of life

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.

Time frame
1 year
2

Improvement in Dyspnea

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.

Time frame
1 year
3

Improvement in COPD-Related Symptoms

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.

Time frame
1 year
4

Total Duration of COPD-Related Hospitalization per 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

Time frame
1 year

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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