NCT02985918终止不适用
Effect of High-Intensity vs Low-Intensity Noninvasive Positive Pressure Ventilation on the Need for Endotracheal Intubation in Patients With an Acute Exacerbation of Chronic Obstructive Pulmonary Disease The HAPPEN Randomized Clinical Trial
Beijing Chao Yang Hospital31 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2019年1月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 300
- 试验地点
- 31
- 主要终点
- The need for endotracheal intubation during hospitalization
研究概览
简要总结
To determine whether high-intensity NPPV, compared with low-intensity NPPV, could reduce the need for endotracheal intubation during hospitalization in patients with an AECOPD and hypercapnia.
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
- Double (Participant, Outcomes Assessor)
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
- •AECOPD confirmed by the 2019 criteria of the Global Initiative for Chronic Obstructive Lung Disease (GOLD)
- •Arterial pH <7.35 and PaCO2 >45 mmHg at screening entry
- •PaCO2 >45 mmHg after a 6-hour trial of low-intensity NPPV
排除标准
- •Age <18 years
- •Excessive respiratory secretions with weak cough
- •Upper airway obstruction
- •Recent oral, facial, or cranial trauma or surgery
- •Recent gastric or esophageal surgery
- •Presence of restrictive ventilatory dysfunction (eg, consolidation or removal of at least one pulmonary lobe, massive pleural effusion, chest wall deformity, continuous strapping with thoracic or abdominal bandage, or severe abdominal distension)
- •Active upper gastrointestinal bleeding
- •Cardiac or respiratory arrest
- •Arterial oxygen tension/fraction of inspired oxygen (PaO2/FiO2) <100 mmHg
- •Pneumothorax
- •Obvious emphysematous bullae confirmed by chest CT scan
- •Ventricular arrhythmia or myocardial ischemia
- •Severe hemodynamic instability (mean arterial pressure <65 mmHg)
- •Severe metabolic acidosis (pH <7.20 and bicarbonate <22 mmol/L)
- •Refusal to receive NPPV or give informed consent
- •Prior endotracheal intubation or tracheostomy during the current hospitalization
- •A do-not-intubate order
结局指标
主要结局
The need for endotracheal intubation during hospitalization
时间窗: From randomization to discharge from hospital
Defined as the proportion of patients who needed for endotracheal intubation during hospitalization after randomization
次要结局
- Live discharge from the hospital(From randomization to discharge from hospital)
- Actual intubation during hospitalization(From randomization to discharge from hospital)
- The composite of actual intubation or avoiding intubation by crossover to high-intensity NPPV(From randomization to discharge from hospital)
- Mortality at day 28(Within 28 days since randomization)
- Intensive care unit admission(From randomization to discharge from hospital)
- Hospital readmission at day 90(Within 90 days since randomization)
- Length of hospital stay after randomization(From randomization to discharge from hospital)
- Invasive ventilator-free days at day 28(Within 28 days since randomization)
- Need for endotracheal intubation at day 28(Within 28 days since randomization)
- NPPV weaning success(From randomization to discharge from hospital)
- Mortality in hospital(From randomization to discharge from hospital)
- Mortality at day 90(Within 90 days since randomization)
- Length of hospital stay(From hospital admission to discharge)
- ICU-free days at day 28(Within 28 days since randomization)
- Actual intubation at day 28(Within 28 days since randomization)
研究者
Zujin Luo
Principal Investigator
Beijing Chao Yang Hospital
研究点 (31)
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