Respiratory Drive Response in COPD Patients During Exercise With Non Invasive Ventilation (NIV).
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- Other: Exercise with spontaneous ventilation.Device: Exercise with NIVDevice: Exercise with HFNC
- Registration Number
- NCT04597606
- Lead Sponsor
- Javier Sayas Catalan
- Brief Summary
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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cohort Exercise with spontaneous ventilation. All patients will be performed a basal test that consist on continuous cyclergometer exercise, under constant load, with spontaneous breathing, after that the same exercise protocol performed will be carried out under non-invasive ventilation (NIV test). Parameters will be titrated previosuly. Finally the patient will perform the same exercise at a constant load under high flow oxygen therapy ( HFNC test). Cohort Exercise with NIV All patients will be performed a basal test that consist on continuous cyclergometer exercise, under constant load, with spontaneous breathing, after that the same exercise protocol performed will be carried out under non-invasive ventilation (NIV test). Parameters will be titrated previosuly. Finally the patient will perform the same exercise at a constant load under high flow oxygen therapy ( HFNC test). Cohort Exercise with HFNC All patients will be performed a basal test that consist on continuous cyclergometer exercise, under constant load, with spontaneous breathing, after that the same exercise protocol performed will be carried out under non-invasive ventilation (NIV test). Parameters will be titrated previosuly. Finally the patient will perform the same exercise at a constant load under high flow oxygen therapy ( HFNC test).
- Primary Outcome Measures
Name Time Method Changes in Neural ventilator (NVU) (%) 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.
- Secondary Outcome Measures
Name Time Method Total Training time (pedaling, minutes) During the exercise at day 4 ( 72 hours later than day 1) Total Time that the patient remains pedaling
Stops (n) During the exercise at day 4 ( 72 hours later than day 1) Number of stops that the patient performs during the test
Borg Scale Dyspnea evolution (points) 72 hours later than day 1 (day 4) during the exercise every 60 seconds Degree of dyspnea will be determined by this validated scale with a result between 1 and 10 points.0: Not at all 0.5: Very, very light (hardly noticeable) 1: Very light, 2: Light, 3: Moderate , 4: Somewhat intense, 5: Intense, 6: Between 5 and 7, 7: Very intense, 8: Between 7 and 9, 9: Very, very intense (almost maximum ), 10: Maximum
Transcutaneous pCO2 Final - inicial (mmHg) During the exercise at day 4 (72 hours later than day 1 ) Transcutaneous monitor uses a noninvasive technique to measure the skin-surface partial pressure of carbon dioxide (PtcCO2)
Ineffective efforts % During the exercise at day 4 ( 72 hours later than day 1) Porcentage of ineffective efforts during the exercise
Trial Locations
- Locations (1)
Javier Sayas Catalan
🇪🇸Madrid, Spain