Clinical trial NCT04597606: Respiratory Drive Response in COPD Patients During Exercise With Non Invasive Ventilation (NIV).
Official title: Non-Invasive Ventilation (NIV) Effect on Neurorespiratory Coupling in Chronic Obstructive Pulmonary Disease During Exercise (COPD).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Noninvasive Ventilation
Exercise
Lead sponsor: Hospital Universitario 12 de Octubre
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recluted from the pneumology outpatient clinic of the Hospital 12 de Octubre

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

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in Neural ventilator (NVU) (%)
timeFrame: 24 hours, 48 hours, 72 hours
Secondary outcomes:
measure: Borg Scale Dyspnea evolution (points)
timeFrame: Basal value at day 1 and every 60 seconds during the exercise
measure: Borg Scale Dyspnea evolution (points)
timeFrame: 24 hours later than day 1 (day 2) during the exercise every 60 seconds
measure: Borg Scale Dyspnea evolution (points)
timeFrame: 48 hours later than day 1 (day 3) during the exercise every 60 seconds
measure: Borg Scale Dyspnea evolution (points)
timeFrame: 72 hours later than day 1 (day 4) during the exercise every 60 seconds
measure: Transcutaneous pCO2 Final - inicial (mmHg)
timeFrame: Basal value at day 1 during the exercise
measure: Transcutaneous pCO2 Final - inicial (mmHg)
timeFrame: During the exercise at day 2 ( 24 hours later than day 1)
measure: Transcutaneous pCO2 Final - inicial (mmHg)
timeFrame: During the exercise at day 3 (48 hours later than day 1)
measure: Transcutaneous pCO2 Final - inicial (mmHg)
timeFrame: During the exercise at day 4 (72 hours later than day 1 )
measure: Total Training time (pedaling, minutes)
timeFrame: During the exercise at day 2 ( 24 hours later than day 1)
measure: Total Training time (pedaling, minutes)
timeFrame: During the exercise at day 3 ( 48 hours later than day 1)
measure: Total Training time (pedaling, minutes)
timeFrame: During the exercise at day 4 ( 72 hours later than day 1)
measure: Stops (n)
timeFrame: During the exercise at day 2 ( 24 hours later than day 1)
measure: Stops (n)
timeFrame: During the exercise at day 3 ( 48 hours later than day 1)
measure: Stops (n)
timeFrame: During the exercise at day 4 ( 72 hours later than day 1)
measure: Ineffective efforts %
timeFrame: During the exercise at day 2 ( 24 hours later than day 1)
measure: Ineffective efforts %
timeFrame: During the exercise at day 3 ( 48 hours later than day 1)
measure: Ineffective efforts %
timeFrame: During the exercise at day 4 ( 72 hours later than day 1)
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Javier Sayas Catalan
Study officials:
affiliation: Hospital 12 de OCtubre
name: Javier Sayas
role: PRINCIPAL_INVESTIGATOR
References: