Non-invasive Ventilation With Automatic Expiratory Positive Airway Pressure Titration to Abolish Tidal Expiratory Flow Limitation in COPD Patients With Chronic Hypercapnia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Mean transcutaneous partial pressure of carbon dioxide (PtcCO2)
研究概览
简要总结
This study aimed to evaluate the effects of a novel automatic non-invasive ventilation (NIV) mode that continuously adjusts expiratory positive airway pressure (EPAP) to the lowest value that abolishes tidal expiratory flow limitation. The investigators conducted a prospective, randomized, cross-over study on stable chronic obstructive pulmonary disease (COPD) patients. Patients were studied in the hospital during two non-consecutive nights while using either fixed or adaptive EPAP. The primary outcome was the transcutaneous partial pressure of carbon dioxide. Secondary outcomes were: oxygen saturation, breathing pattern, oscillatory mechanics, patient-ventilation asynchronies, sleep quality and sleep-related respiratory events.
详细描述
Study design: prospective, randomized, cross-over study. Study population: moderate to severe COPD patients, long-term users of nocturnal non-invasive ventilation for chronic hypercapnic respiratory failure. Inclusion criteria: age<85 years; presence of tidal expiratory flow limitation in the supine position at an expiratory positive airway pressure of 4 cmH2O. Exclusion criteria: COPD exacerbation within the past two months; acute illness; clinical instability.
Study protocol: Patients were studied in the hospital over 2 non-consecutive nights while using either fixed or automatic EPAP.
Ventilation strategy: pressure-controlled NIV was delivered using a non-commercial version of BiPAP Synchrony Ventilator (Philips-Respironics) via an unvented facial mask (AMARA, Philips-Respironics). The ventilator evaluated the presence of tidal expiratory flow limitation by the forced oscillation technique. In the automatic-EPAP mode, the ventilator continuously adjusted EPAP to the minimum level able to abolish tidal expiratory flow limitation, with a minimum EPAP of 4 cmH2O and keeping the pressure support constant.
Measurements: During each study night, the investigators recorded transcutaneous partial pressure of carbon dioxide and oxygen saturation (TOSCA, Radiometer) continuously. Airway opening pressure, flow and volume tracings were exported from the ventilator. Full laboratory polysomnography (Alice5, Philips-Respironics) was performed according to the American Academy of Sleep Medicine recommendations.
Data analysis: the investigators compared parameters from the two nights using Wilcoxon signed-rank test. P-values <0.05 were considered statistically significant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •moderate to severe COPD (GOLD 2017);
- •long-term users of nocturnal non-invasive ventilation for chronic hypercapnic respiratory failure;
- •presence of tidal expiratory flow limitation in the supine position at an expiratory positive airway pressure of 4 cmH2O.
排除标准
- •COPD exacerbation within the past two months;
- •acute illness;
- •clinical instability.
结局指标
主要结局
Mean transcutaneous partial pressure of carbon dioxide (PtcCO2)
时间窗: Overnight (about 8 hours)
The partial pressure of carbon dioxide measures the efficacy of ventilation. Reducing PCO2 is the aim of nocturnal non-invasive ventilation in stable COPD patients with chronic hypercapnia. PCO2 is normally measured non-invasively using a transcutaneous probe during overnight studies.
Percent of night time spent in hypercapnia
时间窗: Overnight (about 8 hours)
Hypercapnia is defined as PtcCO2 \> 45 mm Hg. The aim of non-invasive ventilation in stable COPD patients is to reduce the time spent with PCO2 levels above the physiological range.
次要结局
- Mean peripheral oxygen saturation (SpO2)(Through study completion, an average of 8 hours)
- Desaturation(Through study completion, an average of 8 hours)
- Number of ineffective efforts per hour (IE)(Through study completion, an average of 8 hours)
- Sleep quality(Through study completion, an average of 8 hours)
- EPAP(Through study completion, an average of 8 hours)
- Breathing pattern(Through study completion, an average of 8 hours)
- Difference between mean inspiratory and expiatory reactance(Through study completion, an average of 8 hours)
- Mean inspiratory resistance(Through study completion, an average of 8 hours)
- Mean inspiratory reactance(Through study completion, an average of 8 hours)
- Sleep related respiratory event(Through study completion, an average of 8 hours)
研究者
Raffaele Dellaca
Prof
Politecnico di Milano