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Completed

NCT Number: NCT04597606

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

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.

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Behavior Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Javier Sayas Catalan

Madrid, 28041, Spain

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 NIV

Device

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

Device

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.

Primary outcomes

  1. Changes in Neural ventilator (NVU) (%)

    Time frame: 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 outcomes

  1. Borg Scale Dyspnea evolution (points)

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

    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

  2. Borg Scale Dyspnea evolution (points)

    Time frame: 24 hours later than day 1 (day 2) 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

  3. Borg Scale Dyspnea evolution (points)

    Time frame: 48 hours later than day 1 (day 3) 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

  4. Borg Scale Dyspnea evolution (points)

    Time frame: 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

  5. Transcutaneous pCO2 Final - inicial (mmHg)

    Time frame: Basal value at day 1 during the exercise

    Transcutaneous monitor uses a noninvasive technique to measure the skin-surface partial pressure of carbon dioxide (PtcCO2)

  6. Transcutaneous pCO2 Final - inicial (mmHg)

    Time frame: During the exercise at day 2 ( 24 hours later than day 1)

    Transcutaneous monitor uses a noninvasive technique to measure the skin-surface partial pressure of carbon dioxide (PtcCO2)

  7. Transcutaneous pCO2 Final - inicial (mmHg)

    Time frame: During the exercise at day 3 (48 hours later than day 1)

    Transcutaneous monitor uses a noninvasive technique to measure the skin-surface partial pressure of carbon dioxide (PtcCO2)

  8. Transcutaneous pCO2 Final - inicial (mmHg)

    Time frame: 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)

  9. Total Training time (pedaling, minutes)

    Time frame: During the exercise at day 2 ( 24 hours later than day 1)

    Total Time that the patient remains pedaling

  10. Total Training time (pedaling, minutes)

    Time frame: During the exercise at day 3 ( 48 hours later than day 1)

    Total Time that the patient remains pedaling

  11. Total Training time (pedaling, minutes)

    Time frame: During the exercise at day 4 ( 72 hours later than day 1)

    Total Time that the patient remains pedaling

  12. Stops (n)

    Time frame: During the exercise at day 2 ( 24 hours later than day 1)

    Number of stops that the patient performs during the test

  13. Stops (n)

    Time frame: During the exercise at day 3 ( 48 hours later than day 1)

    Number of stops that the patient performs during the test

  14. Stops (n)

    Time frame: During the exercise at day 4 ( 72 hours later than day 1)

    Number of stops that the patient performs during the test

  15. Ineffective efforts %

    Time frame: During the exercise at day 2 ( 24 hours later than day 1)

    Porcentage of ineffective efforts during the exercise

  16. Ineffective efforts %

    Time frame: During the exercise at day 3 ( 48 hours later than day 1)

    Porcentage of ineffective efforts during the exercise

  17. Ineffective efforts %

    Time frame: During the exercise at day 4 ( 72 hours later than day 1)

    Porcentage of ineffective efforts during the exercise

Sponsors and collaborators

Lead sponsor

Javier Sayas Catalan

Other

Registry information

Official study title

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

Acronym: HFNIV

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Oct 22, 2020
Registry last updated
Nov 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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