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

Pulmonary Disease, Chronic Obstructive Clinical Trial

— HFNIV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04597606
• Other study ID #: NIV and HFNC EXERCISE COPD
• Status: Completed
• Start date: September 2, 2019
• Est. completion date: November 15, 2022

Study information

• Verified date: November 2022
• Source: Hospital Universitario 12 de Octubre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 15, 2022
• Est. primary completion date: November 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Javier Sayas Catalan	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Javier Sayas Catalan

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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 )
Secondary	Total Training time (pedaling, minutes)	Total Time that the patient remains pedaling	During the exercise at day 2 ( 24 hours later than day 1)
Secondary	Total Training time (pedaling, minutes)	Total Time that the patient remains pedaling	During the exercise at day 3 ( 48 hours later than day 1)
Secondary	Total Training time (pedaling, minutes)	Total Time that the patient remains pedaling	During the exercise at day 4 ( 72 hours later than day 1)
Secondary	Stops (n)	Number of stops that the patient performs during the test	During the exercise at day 2 ( 24 hours later than day 1)
Secondary	Stops (n)	Number of stops that the patient performs during the test	During the exercise at day 3 ( 48 hours later than day 1)
Secondary	Stops (n)	Number of stops that the patient performs during the test	During the exercise at day 4 ( 72 hours later than day 1)
Secondary	Ineffective efforts %	Porcentage of ineffective efforts during the exercise	During the exercise at day 2 ( 24 hours later than day 1)
Secondary	Ineffective efforts %	Porcentage of ineffective efforts during the exercise	During the exercise at day 3 ( 48 hours later than day 1)
Secondary	Ineffective efforts %	Porcentage of ineffective efforts during the exercise	During the exercise at day 4 ( 72 hours later than day 1)