High-velocity Nasal Insufflation Versus Non-invasive Mechanical Ventilation in COPD Patients With Acute Hypercapnic Respiratory Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Change in arterial carbon dioxide (PaCO2)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
HVNI group
Patients in this arm receive High-Velocity Nasal Insufflation (HVNI) as the primary non-invasive respiratory support modality for acute hypercapnic respiratory failure. HVNI delivers heated and humidified oxygen at high flow rates to improve oxygenation, reduce work of breathing, and enhance patient comfort.
干预措施: High-Velocity Nasal Insufflation (HVNI) (Device)
NIV group
Patients in this arm receive Non-Invasive Ventilation (NIV) as the standard non-invasive ventilatory support for acute hypercapnic respiratory failure. NIV provides positive pressure ventilation via mask to improve alveolar ventilation, reduce PaCO2, and correct respiratory acidosis.
干预措施: Non-Invasive Ventilation (NIV) (Device)
结局指标
主要结局
Change in arterial carbon dioxide (PaCO2)
时间窗: Baseline and 1 hour after randomization
次要结局
- Change from baseline in arterial carbon dioxide (PaCO₂)(Baseline to 24 hours after randomization)
- Change in arterial pH from baseline to 24 hours after randomization(Baseline and 24 hours after randomization)
- Change from baseline in respiratory rate(Baseline to 24 hours after randomization)
- Length of hospital stay(Up to 30 days)
- Need for escalation to invasive mechanical ventilation(Up to 4 days after randomization)
- Change in arterial pH from baseline to 24 hours after randomization(Baseline and 24 hours)
研究者
Rania Abdelkareem Abdelraoof
Specialist at Damanhur Chest Hospital
Al-Azhar University