Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Brief 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.
Detailed description
This study is a prospective randomized controlled trial conducted on adult patients diagnosed with acute exacerbation of chronic obstructive pulmonary disease (AECOPD) complicated by acute hypercapnic respiratory failure (type II respiratory failure), admitted to the respiratory intensive care unit or emergency department. COPD is a leading cause of morbidity and mortality worldwide, and acute exacerbations associated with hypercapnic respiratory failure represent a major cause of hospital admission and intensive care utilization. Non-invasive ventilation (NIV) is the standard of care in such cases; however, its use may be limited by patient intolerance, discomfort, and contraindications. High-Flow Nasal Insufflation (HVNI) is an emerging non-invasive respiratory support modality that delivers heated, humidified oxygen at high flow rates, generating low levels of positive airway pressure, reducing dead space ventilation, and improving oxygenation and ventilation. It may offer improved patient comfort and tolerance compared to NIV. In this study, eligible patients will be randomly assigned into two groups: Group I: High-Flow Nasal Insufflation (HVNI) Group II: Non-Invasive Ventilation (NIV) Baseline clinical data, arterial blood gases, and severity scores will be recorded. Patients will be monitored for clinical and laboratory response. The primary endpoint is the mean difference in PaCO2 to evaluate the short-term effect of HVNI and NIV from baseline to one hour after randomization. The secondary endpoints include the following outcomes: Treatment change rates (switch to other ventilatory support modality due to clinical deterioration) Proportion of patients with PaCO2 worsening or reduction less than 10 mmHg from baseline, or no improvement in dyspnea Respiratory rate Changes in arterial blood gases Duration of mechanical ventilation (invasive and non-invasive) Length of hospital stay In-hospital mortality
Interventions
DEVICEHigh-Velocity Nasal Insufflation (HVNI)
High-velocity nasal insufflation delivering heated and humidified oxygen at high flow rates through nasal cannula. It provides low level positive airway pressure, washout of anatomical dead space, reduction of work of breathing, and improvement in oxygenation and ventilation in patients with acute hypercapnic respiratory failure.
Non-invasive ventilation delivered via face mask providing positive pressure support to improve alveolar ventilation, decrease PaCO2, correct respiratory acidosis, and reduce work of breathing in patients with acute hypercapnic respiratory failure.
Sponsors
Al-Azhar University
Study design
Allocation
NA
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants will be randomly assigned in a 1:1 ratio into two parallel groups: one receiving High-Flow Nasal Insufflation (HVNI) and the other receiving Non-Invasive Ventilation (NIV). Outcomes will be compared between the two groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in arterial carbon dioxide (PaCO2) | Baseline and 1 hour after randomization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Need for escalation to invasive mechanical ventilation | Up to 4 days after randomization | Proportion of patients requiring invasive mechanical ventilation |
| Change in arterial pH from baseline to 24 hours after randomization | Baseline and 24 hours | — |
| Change from baseline in arterial carbon dioxide (PaCO₂) | Baseline to 24 hours after randomization | — |
| Change from baseline in respiratory rate | Baseline to 24 hours after randomization | — |
| Length of hospital stay | Up to 30 days | — |
Countries
Egypt
Contacts
STUDY_DIRECTOREman Mostafa moazen, MD,PhD
Al-Azhar University, Faculty of Medicine
PRINCIPAL_INVESTIGATOREntsar Sayed ahmed, MD,PhD
Faculty of Medicine al Azhar University
STUDY_DIRECTORMagd Mohamed Galal, MD, PhD
Faculty of Medicine al Azhar University
Outcome results
None listed