Respiratory Drive Response in COPD Patients During Exercise With Non Invasive Ventilation (NIV).

Javier Sayas Catalan12 enrolled

Overview

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.

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Exercise with spontaneous ventilation.OTHER

Patients will perform 10 minutes, constant load, exercise in a cycloergometer. To set the load, a baseline incremental effort test will be performed previously (VISIT 1). Then, in a separate day (VISIT 2), the subject will perform 10 minutes cycling at the 75% load of that determined as maximum in VISIT 1, at a constant rate of 30 to 35 pedal revolutions per minute, in spontaneous breathing, with low flow oxygen through conventional nasal cannula adjusted to achieve SpO2 between 92to 94%

Exercise with NIVDEVICE

VISIT 2 Non invasive mask ventilation: parameters will be titrated during a free cycling period at the end of the spontaneous breathing exercise. Then, in a separate day (VISIT 3), with the same constant load, cycling cadence and under NIV, the patient will perform 10 min of cycling.

Exercise with HFNC

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Locations (1)

Javier Sayas Catalan

Madrid, Spain

Outcomes

Primary Outcomes

Changes in Neural ventilator (NVU) (%)

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.

Time frame: 24 hours, 48 hours, 72 hours

Secondary Outcomes

Borg Scale Dyspnea evolution (points)

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

Time frame: Basal value at day 1 and every 60 seconds during the exercise

Borg Scale Dyspnea evolution (points)

Time frame: 24 hours later than day 1 (day 2) during the exercise every 60 seconds

Borg Scale Dyspnea evolution (points)

Data from ClinicalTrials.gov

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