Nasal High Flow in Early Management of Patients Admitted to the Emergency Department for Acute Exacerbation of Chronic Obstructive Pulmonary Disease With Hypercapnic Acidosis : a Randomized Controlled Non Inferiority Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 174
- 试验地点
- 3
- 主要终点
- Change in PaCO2
研究概览
简要总结
The purpose of this study is to determine whether nasal high flow is non inferior to non invasive ventilation (NIV) in the early treatment of patients with acute exacerbation of chronic obstructive pulmonary disease (AE-COPD) and hypercapnic acidosis in the emergency department (ED). After obtaining informed consent, participants will be randomly assigned to receive either nasal high flow or non invasive ventilation (NIV, reference treatment) as respiratory support. Researchers will compare both respiratory support groups to see if their blood gas analysis and respiration return to normal ranges.
详细描述
Prospective multicenter comparative therapeutic study, with a randomized controlled parallel and open design. Nasal high flow will be compared to NIV (reference treatment) for early treatment of AE-COPD associated with hypercapnic acidosis.
Adult patients admitted to the ED for AE-COPD with hypercapnic acidosis will be randomized to receive either nasal high flow or NIV as ventilatory support. Ventilatory support will be applied in 2h sessions and resumed as needed according to international guidelines for NIV treatment. Close monitoring of clinical and gas parameters will be conducted with repeat assessment and serial blood gas testing at 2h and after each 2h session of respiratory support in the ED (2h, 4h, 6h) and at 24h.
Standard oxygen therapy will be administered as required between ventilatory support sessions to maintain a target peripheral oxygen saturation (SpO2 : 88-92%).
Patient's dyspnea and comfort will be assessed before treatment and at 2h, and after each respiratory support session in the ED Patients will receive standard medical treatment for AE-COPD (bronchodilator, corticosteroids and antibiotics) according to current practice and 2023 global initiative guidelines for the management of COPD (GOLD).
Patients will be followed up at day 28 by means of medical records review and telephone interview
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Masking non feasible
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult Patient admitted to the ED for acute exacerbation of COPD (AE-COPD)and respiratory acidosis (PaCO2 > 45 mmHg and pH <7.35), for whom ventilatory assistance by NIV is indicated (SPLF 2017, GOLD2023 recommendations)
- •Inclusion Criteria:
- •Patients with ability to understand and give an informed consent
- •Patients affiliated with or who benefit from a social security
- •Patients admitted to the emergency department for a clinical suspicion of AE-COPD based on clinical history, physical examination and chest X-ray (SPLF 2017)
- •Patients with acute respiratory failure defined by: Respiratory rate ≥ 25 bpm AND/OR Signs of respiratory failure (use of accessory respiratory muscles, paradoxical abdominal movement)
- •Patients with respiratory acidosis defined by PaCO2 > 45 mmHg AND pH < 7.35 (measured on arterial blood gas)
排除标准
- •Patients who have already received NIV treatment before inclusion (including in-hospital or prehospital, with the exception of NIV at home)
- •Contraindication to non-invasive ventilation (SPLF 2017 and GOLD 2023 recommendations)
- •Patient uncooperative, agitated, opponent of the technique
研究组 & 干预措施
Non invasive ventilation
NIV will be delivered through a face mask connected to a ventilator with pressure support applied in a noninvasive ventilation mode.
The Pressure-support level will be adjusted to obtain an expired tidal volume of 6-8 ml/kg of predicted body weight and a respiratory rate of 25-30 b/min. PEEP (range 5-10 cm of water) and FiO2 will be adjusted to maintain an SpO2 88-92% and to patient's comfort.
Ventilatory support will be applied in 2h sessions and resumed as needed according to international guidelines for NIV treatment.
干预措施: Ventilatory support via NIV (Device)
Nasal high flow
Nasal high flow will be administered through a heated humidifier (Airvo 3, Fisher and Paykel healthcare) and applied through large bore binasal prongs.
Initial gas flow rate will be set at 60 l/min, FiO2 will be adjusted to maintain an SpO2 88-92% and Initial temperature will be set at 37° and reduced according to patient's tolerance.
Ventilatory support will be applied in 2h sessions and resumed as needed according to international guidelines for NIV treatment
干预措施: Ventilatory support via nasal high flow (Device)
结局指标
主要结局
Change in PaCO2
时间窗: 2 hours
PaCO2 will be measured from standard laboratory arterial blood gas analysis before the initiation of ventilatory assistance and after 2 hours of treatment
次要结局
- Change in PaCO2(up to 24 hours)
- Change in PaO2(up to 24 hours)
- Perceived dyspnea(up to 24 hours)
- Weaning from ventilatory support(Up to Day 28)
- Change in pH(up to 24 hours)
- Treatment failure (composite of change of treatment arm / need for invasive mechanical ventilation/ mortality)(Up to Day 28)
- Respiratory rate(up to 24 hours)
- Signs of increased work of breathing (use of accessory respiratory muscles, paradoxical motion of the abdomen)(up to 24 hours)
- Change in pH(2 hours)
- Change in PaO2(2 hours)