Influence of Ventilator Model and Pressure Support Level in Muscular Unloading in COPD Patients With Non Invasive Ventilation (NIV)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- Inspiratory muscular unloading (µv)
研究概览
简要总结
Evaluation of high intensity NIMV in terms of physiological parameters has been performed in short-term studies in COPD patients. However, the support pressure levels used in exacerbated patients seem contradictory and the muscular unloading levels are uncertain. The objective of study is to determine the discharge level of the inspiratory musculature reached at the same pressure support (PS) values in a group of hospital and domiciliary ventilators. Patients with COPD in at least 6 months of treatment with home NIMV and in stable phase of their disease will be included. Eight commercial ventilators will be used, each patient will use 2 different ventilators. A 5 minute record will be taken at baseline (without NIMV). Subsequently, 5 minutes in NIMV in 3 levels of PS (15/10/20) for each ventilator (15/10/20) and patient with expiratory positive airway pressure (EPAP) of 5 centimeters of water (cmH2O) will be recorded. The results will be compared between the different ventilators and PS values using a general linear model for repeated variables to determine the differences between ventilators and PS levels of respiratory muscular unloading in COPD patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with COPD diagnoses based on a spirometry performed the previous year during stability.
- •COPD patients with home NIV treatment of at least 6 months with acceptable compliance and adaptation.
- •Stable patients or just before hospital discharge due to an exacerbation with gasometric stability.
排除标准
- •Respiratory acidosis in blood gas analysis, just in case of recent exacerbation
- •Patients with restrictive pathology and /or obesity (IMC>35)
- •Poor quality of EMG signals.
结局指标
主要结局
Inspiratory muscular unloading (µv)
时间窗: 1 day
Differences in parasternal electromyogram (EMG) signals interpretation between the record of ventilator 1 and ventilator 2.
次要结局
- Pressure support 10 EMG (µv) record. V1(1 day)
- Pressure support 10 EMG (µv) record. V2(1 day)
- Pressure support 20 EMG (µv) record. V2(1 day)
- Baseline EMG (µv) record(1 day)
- Pressure support 15 EMG (µv) record. V1(1 day)
- Pressure support 20 EMG (µv) record. V1(1 day)
- Pressure support 15 EMG (µv) record. V2(1 day)
研究者
Manel Lujan-Torne
MD
Corporacion Parc Tauli
