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

Non-Invasive Ventilation (NIV) Effect on Neurorespiratory Coupling in Chronic Obstructive Pulmonary Disease During Exercise (COPD).

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Other: Exercise with spontaneous ventilation.; Device: Exercise with NIV; Device: Exercise with HFNC

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

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28041
    • Javier Sayas Catalan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients will be recluted from the pneumology outpatient clinic of the Hospital 12 de Octubre

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Cohort; 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).

Other: Exercise with spontaneous ventilation.; 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%; Device: Exercise with NIV; 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.; Device: Exercise with HFNC; With constant flows of 50 lpm and with FiO2 adjusted according to SPO2, to obtain a constant saturation between 92 and 94%. The same pedaling load and frequency will be maintained, with similar variables collected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 hours, 48 hours, 72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Basal value at day 1 and every 60 seconds during the exercise
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	24 hours later than day 1 (day 2) during the exercise every 60 seconds
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	48 hours later than day 1 (day 3) during the exercise every 60 seconds
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	72 hours later than day 1 (day 4) during the exercise every 60 seconds
Transcutaneous pCO2 Final - inicial (mmHg)	Transcutaneous monitor uses a noninvasive technique to measure the skin-surface partial pressure of carbon dioxide (PtcCO2)	Basal value at day 1 during the exercise
Transcutaneous pCO2 Final - inicial (mmHg)	Transcutaneous monitor uses a noninvasive technique to measure the skin-surface partial pressure of carbon dioxide (PtcCO2)	During the exercise at day 2 ( 24 hours later than day 1)
Transcutaneous pCO2 Final - inicial (mmHg)	Transcutaneous monitor uses a noninvasive technique to measure the skin-surface partial pressure of carbon dioxide (PtcCO2)	During the exercise at day 3 (48 hours later than day 1)
Transcutaneous pCO2 Final - inicial (mmHg)	Transcutaneous monitor uses a noninvasive technique to measure the skin-surface partial pressure of carbon dioxide (PtcCO2)	During the exercise at day 4 (72 hours later than day 1 )
Total Training time (pedaling, minutes)	Total Time that the patient remains pedaling	During the exercise at day 2 ( 24 hours later than day 1)
Total Training time (pedaling, minutes)	Total Time that the patient remains pedaling	During the exercise at day 3 ( 48 hours later than day 1)
Total Training time (pedaling, minutes)	Total Time that the patient remains pedaling	During the exercise at day 4 ( 72 hours later than day 1)
Stops (n)	Number of stops that the patient performs during the test	During the exercise at day 2 ( 24 hours later than day 1)
Stops (n)	Number of stops that the patient performs during the test	During the exercise at day 3 ( 48 hours later than day 1)
Stops (n)	Number of stops that the patient performs during the test	During the exercise at day 4 ( 72 hours later than day 1)
Ineffective efforts %	Porcentage of ineffective efforts during the exercise	During the exercise at day 2 ( 24 hours later than day 1)
Ineffective efforts %	Porcentage of ineffective efforts during the exercise	During the exercise at day 3 ( 48 hours later than day 1)
Ineffective efforts %	Porcentage of ineffective efforts during the exercise	During the exercise at day 4 ( 72 hours later than day 1)

Collaborators and Investigators

• Sponsor: Javier Sayas Catalan
• Investigators: Principal Investigator: Javier Sayas, Hospital 12 de Octubre

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2019
• Primary Completion (Actual): November 15, 2022
• Study Completion (Actual): November 15, 2022

Study Registration Dates

• First Submitted: September 18, 2020
• First Submitted That Met QC Criteria: October 15, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): November 23, 2022
• Last Update Submitted That Met QC Criteria: November 20, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Exercise; Noninvasive Ventilation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: NIV and HFNC EXERCISE COPD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No