Non-Invasive Ventilation (NIV) Effect on Neurorespiratory Coupling in Chronic Obstructive Pulmonary Disease During Exercise (COPD).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Changes in Neural ventilator (NVU) (%)
研究概览
简要总结
A constant load exercise during 10 minutes will be performed in a group of Chronic Obstructive Pulmonary Disease patients, in a basal condition (spontaneous breathing); under noninvasive mask ventilation and with high flow nasal cannula. With the aim of reducing dyspnea, increasing exercise tolerance, and unload respiratory muscles, three exercises will be compared in terms of use of respiratory muscles and neural drive measured with paraesternal electromyography.
详细描述
Exercise in chronic obstructive pulmonary disease is limited by dynamic hyperinflation and respiratory muscle overloadleading to severe dyspnea. During exercise, the increase in neural respiratory drive is notable to match ventilatory demand, correlated with breathlessness. Non-Invasive Ventilation may improve neural respiratory drive uncoupling and exercise tolerance. The aim of this study will be prove if Non-Invasive Ventilation and High flow nasal cannula during exercise reduces neural respiratory drive and improves dyspnea, measured with paraesternal electromyography
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients with severe COPD or cystic fibrosis (with an obstructive pattern and air trapping) on the waiting list for a lung transplant, assessed by the Lung Transplant Unit of the 12 de Octubre University Hospital.
- •Diagnostic criteria for COPD according to the GOLD and residual volume greater than 120% of theoretical
- •Evidence of developing dynamic air trapping by analyzing flow / volume curves during physical exercise.
- •Patients already adapted to home noninvasive mechanical ventilation (NIV) waiting for transplantation.
排除标准
- •Presence of comorbidities that limit the patient's physical effort capacity (uncontrolled ischemic heart disease, severe pulmonary hypertension, neuromuscular disease).
- •Refusal of treatment with NIV, or inclusion in the study.
- •Inability to perform the proposed exercise in basal conditions and with ventilation.
结局指标
主要结局
Changes in Neural ventilator (NVU) (%)
时间窗: 24 hours, 48 hours, 72 hours
the peak value (on the baseline) of the maximum muscle activity ( Root mean square EMG value in mV), both diaphragmatic (EMGDimax) and parasternal (EMGparamax) in the máximum intentional ventilation and maximum inspiratory peak (MIP) will be taken. This value will be consider 100% and based on this mean EMG will be calculate for a normalized EMGdi (RMS) and paraesternal in each ventilatory situation (spontaneous ventilation or under NIV). At each effort point (in each minute of the exercise protocol), the relationship between the normalized EMG value (parasternal and Diaphragmatic) and the tidal volume (obtained by integral of flow signal by means of a pneumotachograph connected to the VM -in NIV- or oronasal hermetic mask -in Vesp). To facilitate the interpretation of the expired TV, the mask without leakage will be used with the intentional leak connected in the circuit, before the pneumotachograph.
次要结局
- Total Training time (pedaling, minutes)(During the exercise at day 4 ( 72 hours later than day 1))
- Stops (n)(During the exercise at day 4 ( 72 hours later than day 1))
- Borg Scale Dyspnea evolution (points)(72 hours later than day 1 (day 4) during the exercise every 60 seconds)
- Transcutaneous pCO2 Final - inicial (mmHg)(During the exercise at day 4 (72 hours later than day 1 ))
- Ineffective efforts %(During the exercise at day 4 ( 72 hours later than day 1))
研究者
Javier Sayas Catalan
Principal Investigator: Javier Sayas Catalan, Medical Doctor
Hospital Universitario 12 de Octubre