EMG Measurements of Respiratory Muscles for the Titration of Nocturnal Non-invasive Ventilation in Stable Chronic Obstructive Pulmonary Disease Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Nocturnal gas exchange (PCO2 (kPa))
研究概览
简要总结
The aim of the present study is to investigate whether additional titration on surface electromyography (EMG) of the diaphragm and intercostal muscles improves the outcome of chronic non-invasive ventilation in patients with COPD and stable chronic hypercapnic respiratory failure in terms of better gas exchange after six weeks, lung function, patient comfort and compliance, and less patient ventilator asynchrony. Therefore, the investigators set up a randomized, two-armed crossover trial comparing regular titration with additional respiratory EMG titration of NIV.
详细描述
Rationale:
Long-term application of nocturnal non-invasive ventilation (NIV) in stable hypercapnic chronic obstructive pulmonary disease (COPD) patients has long been controversial as study results were not unequivocal. However, in the past 7 years, with a change in ventilatory strategy, clear benefits of chronic NIV have been shown in COPD patients with chronic hypercapnic respiratory failure (CHRF), though only in stable disease. As a consequence, this so called high-intensity NIV, which is the concept of using higher positive inspiratory airway pressures (IPAP) levels than used in most of the older trials in addition to controlled ventilation with higher backup breathing frequencies aiming for maximal arterial carbon dioxide (PaCO2) reduction, has gained increasing attention.
However, it is unknown how high-intensity NIV works, and how to titrate the optimal IPAP and optimal backup breathing frequency. Measuring respiratory muscle activity might be a way to titrate NIV in COPD.
Objective:
The aim of the present study is to investigate whether additional titration on surface electromyography (EMG) of the diaphragm and intercostal muscles improves outcomes of chronic NIV in patients with COPD and stable CHRF in terms of better gas exchange after six weeks, lung function, patient comfort and compliance and less patient-ventilator asynchrony (PVA).
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
- 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
- •Chronic Obstructive Pulmonary Disease (COPD) Global initiative of chronic Obstructive Lung Diseases (GOLD) stage III or IV (FEV1 <50 % predicted, FEV1/forced expiratory volume (FVC) < 70% predicted)
- •Indication for the initiation of chronic NIV: PaCO2 >6.0 kilopascal (kPa) at rest during daytime.
- •Stable COPD (pH >7.35, no exacerbation in the past two weeks)
- •Age >18 years
排除标准
- •Respiratory insufficiency of any other cause.
- •Already initiated on chronic NIV.
结局指标
主要结局
Nocturnal gas exchange (PCO2 (kPa))
时间窗: 6 weeks
PCO2 will be assessed with transcutaneous measurements (TOSCA, Linde Medical Sensors AG, Basel)
次要结局
- Patient comfort measured with a Visual Analogue Scale(6 weeks)
- Health related quality of life measured with the Severe Respiratory Insufficiency (SRI) questionaire(6 weeks)
- Lung volumes(6 weeks)
- Respiratory muscle strength(6 weeks)
- Patient-Ventilator Asynchrony (PVA)(6 weeks)
研究者
Marieke Duiverman
Dr.
University Medical Center Groningen