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NCT Number: NCT04014868

During-exercise Physiological Effects of Nasal High-flow in Patients With Chronic Obstructive Pulmonary Disease

Chronic obstructive pulmonary disease is a major cause of disability and mortality worldwide. This disease progressively leads to dyspnea and exercise capacity impairment. Pulmonary rehabilitation teaches chronic obstructive pulmonary disease patients to cope effectively with the systemic effects of the disease and improves exercise capacity, dyspnea and quality of life in patients with chronic obstructive pulmonary disease. However, the best training modality remains unknown. Physiological studies highlight the benefit of high intensity endurance training. However, many patients do not tolerate such a training due to ventilatory limitation and dyspnea. Therefore, a strategy to reduce dyspnea would allow a greater physiological muscle solicitation and improvement. Thus, many studies focus on means to increase exercise tolerance in patients with chronic obstructive pulmonary disease.

Nasal high flow delivers heated and humidified high flow air (up to 60 L/min) through nasal cannula providing physiological benefits such as positive airway pressure and carbon dioxide washout. It can be used in association with oxygen and offers the advantage to overtake the patient's inspiratory flow, providing a stable inspired fraction of oxygen. Nasal high flow has widely been studied in pediatric and adult intensive care units and seems better than conventional oxygen therapy and as effective as noninvasive ventilation with regards to mortality to treat hypoxemic acute respiratory failure.

More recently, nasal-high flow has been shown to improve endurance exercise capacity in patients with chronic obstructive pulmonary disease. However, the underlying physiological mechanisms have not been yet elucidated but may help to optimise the utilization of the device.

Therefore, the primary objective of this study is to assess the respiratory physiological effects nasal high-flow during-exercise in stable patients with chronic obstructive pulmonary disease.

Secondary objectives are to assess the effects nasal high-flow during-exercise on endurance capacity, respiratory drive, dynamic hyperinflation, cardiorespiratory pattern and muscular metabolism.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ADIR Association

Bois-Guillaume, 76230, France

About this study

Experimental design:

Patients referred for pulmonary rehabilitation will be approached to participate in this study. Eligible patients who agree to participate in the study and sign informed consent will perform two constant workload exercise testing the same day with either nasal high-flow or sham nasal high-flow (separated by a 1 hour rest-period) in a randomized order.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age > 18years and < 80years;
  • Chronic obstructive pulmonary disease Gold III-IV;
  • Stable (no exacerbation) in the past 4 weeks;
  • Referred for pulmonary rehabilitation (no cardiac, neurological, orthopedic, neuromuscular, psychological or psychiatric contra indication).

Non-inclusion Criteria:

  • Acute exacerbation of chronic obstructive pulmonary disease between the incremental cardiopulmonary exercise testing and inclusion;
  • Tracheostomy;
  • Nasal high flow intolerance;
  • Pregnancy or likely to be;
  • Unable to consent;
  • Patients under guardianship.

Treatment and study plan

Nasal high-flow

Device

See arm description.

Sham nasal high-flow

Other

See arm description.

Primary outcomes

  1. Transdiaphragmatic pressure-time product using a single-use catheter with two balloons to measure gastric and esophageal pressures.

    Time frame: The outcome will be continuously recorded during the two constant workload exercise testing. The 2 tests will be performed the same day for a total time frame of 3hours.

    Transdiaphragmatic pressure is calculated as gastric pressure minus oesophageal pressure. The outcome will be continuously recorded during the two constant workload exercise testing. Results will be shown at time limit and iso time (defined as time limit of the shortest test).

Secondary outcomes

  1. Ventilatory drive using diaphragmatic electromyogram through the same single-use catheter used for transdiaphragmatic pressure (which is provided with 6 pairs of electrodes).

    Time frame: The outcome will be continuously recorded during the two constant workload exercise testing. The 2 tests will be performed the same day for a total time frame of 3hours.

    Diaphragmatic electromyography will be recorded with 6 pairs of electrodes and will be used as a surrogate for ventilatory drive. Results will be shown at time limit and iso time (defined as time limit of the shortest test).

  2. Ventilatory efficiency using indirect calorimetry

    Time frame: The outcome will be continuously recorded during the two constant workload exercise testing. The 2 tests will be performed the same day for a total time frame of 3hours.

    Ventilatory efficiency will be assessed as the ratio between exercise ventilation to carbon dioxide production. Results will be shown at time limit and iso time (defined as time limit of the shortest test).

  3. Dynamic hyperinflation using the fall in during-exercise inspiratory capacity

    Time frame: The outcome will be recorded during the two tests. The 2 tests will be performed the same day for a total time frame of 3hours.

    Maximal inspiratory maneuver will be performed every minute during the two constant workload exercise testing. Results will be shown at time limit and iso time (defined as time limit of the shortest test).

  4. Transcutaneous arterial carbon dioxide partial pressure using capnography.

    Time frame: The outcome will be continuously recorded during the two constant workload exercise testing. The 2 tests will be performed the same day for a total time frame of 3hours.

    The outcome will be measured at the earlobe. Results will be shown at time limit and iso time (defined as time limit of the shortest test).

  5. Dyspnea during the constant workload exercise testing using modified Borg scale (0-10).

    Time frame: The outcome will be recorded during the two tests. The 2 tests will be performed the same day for a total time frame of 3hours.

    Borg scale range from 0 (no breathlessness) to 10 (maximal breathlessness). The dyspnea will be assessed every 30sec during the constant workload exercise testing. Results will be shown at time limit and iso time (defined as time limit of the shortest test).

  6. Vastus lateralis muscle peripheral perfusion during exercise using near infrared spectroscopy.

    Time frame: The outcome will be recorded during the two tests. The 2 tests will be performed the same day for a total time frame of 3hours.

    The outcome will be assessed every minute. Peripheral muscle perfusion will be assessed using the linear increase in total haemoglobin and myoglobin during a venous occlusion (20 seconds) and used as a surrogate for local blood perfusion. Results will be shown at time limit and iso time (defined as time limit of the shortest test).

  7. Vastus lateralis muscular peripheral oxygen extraction during exercise using near infrared spectroscopy.

    Time frame: The outcome will be recorded during the two tests. The 2 tests will be performed the same day for a total time frame of 3hours.

    The outcome will be assessed continuously. Vastus lateralis muscle oxygen extraction will be assessed using deoxyhaemoglobin and deoxymyoglobin as a surrogate for peripheral oxygen extraction. Results will be shown at time limit and iso time (defined as time limit of the shortest test).

  8. Endurance exercise capacity in seconds.

    Time frame: The outcome will be measured after every test. Data will be continuously collected during the tests. The 2 tests will be performed the same day for a total time frame of 3hours.

    Patients will perform a constant workload exercise testing at 75% of the maximal workload achieved during the incremental cardiopulmonary exercise testing.

Sponsors and collaborators

Lead sponsor

ADIR Association

Other

Registry information

Acronym: AIRVO-PHYSIO

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 10, 2019
Registry last updated
Mar 17, 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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