Efficacy of High-intensity Noninvasive Positive Pressure Ventilation and Low-intensity Noninvasive Positive Pressure Ventilation in Patients With Chronic Hypercapnic Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Partial pressure of arterial blood carbon dioxide (PaCO2)
研究概览
简要总结
High-intensity noninvasive positive pressure ventilation (NPPV), which can well improve the gas exchange and reduce the work of breathing of patients, is a new strategy targeted at maximally reducing arterial carbon dioxide. However, no definitive conclusions have been drawn to decide whether high-intensity NPPV is the best setting for treating patients with chronic hypercapnic COPD. For now, no unified method for setting up high-pressure NPPV has been established. Most of the trials utilized gradually increased inspiratory positive airway pressure depending on the patient's tolerance. However, from a respiratory physiology point of view, excessive inspiratory positive airway pressure may lead to lung hyperinflation, increased intrinsic positive end expiratory pressures, increased oxygen consumption, and ineffective work of breathing.Therefore, seeking a method to establish individualized high-intensity NPPV is of vital importance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically stable with chronic hypercapnic COPD (baseline arterial carbon dioxide pressure (PaCO2) of 50 mmHg or higher, measured resting in a sitting position and breathing room air without having used NPPV for at least 1 hour)
排除标准
- •other lung/pleural diseases or thoracic deformity
- •severe heart failure (New York Heart Association class IV), severe dysrhythmia
- •unstable angina, or malignant comorbidity
- •obesity (BMI ≥ 35 kg/m²)
- •severe obstructive sleep apnea syndrome
结局指标
主要结局
Partial pressure of arterial blood carbon dioxide (PaCO2)
时间窗: 12 weeks
Daytime arterial blood gas samples were taken with patients resting in a sitting position and breathing room air without having used NPPV for at least 1 hour.
次要结局
- COPD assessment test(12 weeks)
- Chromic Respiratory Questionnaire(12 weeks)
- Severe Respiratory Insufficiency (SRI) Questionnaire(12 weeks)
- Baseline Dyspnea Index/Transition Dyspnea Index(12 weeks)
- Pulmonary function(12 weeks)
- 6-minute walk test(12 weeks)
研究者
Guan Lili
Principal Investigator
The First Affiliated Hospital of Guangzhou Medical University