CompletedNot Applicable

High Velocity Nasal Insufflation Versus Non Invasive Ventilation in COPD Patients With Acute Hypercapnic Respiratory Failure

Egypt66 participantsStarted 2023-07-01

Plain-language summary

This study is a randomized clinical trial that compares two methods of non-invasive respiratory support in patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD) complicated by acute hypercapnic respiratory failure. Eligible adult patients admitted with this condition will be randomly assigned to receive either High-Flow Nasal Insufflation (HVNI) or Non-Invasive Ventilation (NIV). The main goal of the study is to evaluate changes in blood gas levels, especially carbon dioxide (PaCO2), after one hour of treatment. Secondary outcomes include the need for invasive ventilation, length of hospital stay, changes in breathing rate, and in-hospital outcomes. The study aims to determine whether HVNI can provide a safe and effective alternative to NIV in this group of patients.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Adults aged ≥18 years Diagnosis of acute exacerbation of COPD (AECOPD) Acute hypercapnic respiratory failure (PaCO2 \> 45 mmHg with acidosis or indication for ventilatory support) Indication for non-invasive ventilatory support Hemodynamically stable patients Ability to provide informed consent or legal representative consent Exclusion Criteria: Age \<18 years Immediate need for invasive mechanical ventilation (e.g., apnea, respiratory arrest, severe respiratory distress) Severe hypoxemia (PaO2 \< 55 mmHg despite oxygen therapy) Severe acidosis (pH \< 7.25) with hypercapnia Neuromuscular disease Unstable hemodynamics (SBP \< 90 mmHg or MAP \< 65 mmHg despite resuscitation) Hypercapnic respiratory failure due to non-COPD causes Contraindications to HVNI or NIV (facial trauma, obstruction, severe agitation, etc.) Pregnancy BMI \> 30 kg/m²

What they're measuring

Change in arterial carbon dioxide (PaCO2)

Timeframe: Baseline and 1 hour after randomization

Trial details

NCT IDNCT07561177

SponsorAl-Azhar University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-01