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

NCT07198880 | Not Yet Recruiting

• 1 other identifier: NIV in COPD Patients
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Changes in arterial blood gas parameter "PaCO₂"

  follow up PaCo2 level measured by mmhg

  1 year

• Assessment of Adherence to BiPAP therapy

  measured as the average hours of nightly use

  1 year

Secondary Outcomes (6)

• Improvements in quality of life

  1 year

• Improvement in Dyspnea

  1 year

• Improvement in COPD-Related Symptoms

  1 year

• Total Duration of COPD-Related Hospitalization per Year

  1 year

• Number of COPD-Related Hospitalizations per Year

  1 year

Study Arms (2)

NIV Group

EXPERIMENTAL

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.

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

Control Group

ACTIVE COMPARATOR

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

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

Interventions

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

NIV Group

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

Control Group; NIV Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Hypercapnia

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Central Study Contacts

Mostafa Mahmoud Ahmed

CONTACT

0201001554241; doc.mostafa5454@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 14, 2025
• First Posted: September 30, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: September 30, 2025

Record last verified: 2025-09