Clinical trial NCT04014868: During-exercise Physiological Effects of Nasal High-flow in Patients With Chronic Obstructive Pulmonary Disease
Official title: During-exercise Physiological Effects of Nasal High-flow in Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic obstructive pulmonary disease
Exercise
Nasal high flow
Muscle
Lead sponsor: ADIR Association
Sponsor class: OTHER
First posted: 2019-07-10
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Single-blind randomized cross-over study.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Transdiaphragmatic pressure-time product using a single-use catheter with two balloons to measure gastric and esophageal pressures.
timeFrame: 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.
Secondary outcomes:
measure: Ventilatory drive using diaphragmatic electromyogram through the same single-use catheter used for transdiaphragmatic pressure (which is provided with 6 pairs of electrodes).
timeFrame: 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.
measure: Ventilatory efficiency using indirect calorimetry
timeFrame: 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.
measure: Dynamic hyperinflation using the fall in during-exercise inspiratory capacity
timeFrame: 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.
measure: Transcutaneous arterial carbon dioxide partial pressure using capnography.
timeFrame: 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.
measure: Dyspnea during the constant workload exercise testing using modified Borg scale (0-10).
timeFrame: 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.
measure: Vastus lateralis muscle peripheral perfusion during exercise using near infrared spectroscopy.
timeFrame: 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.
measure: Vastus lateralis muscular peripheral oxygen extraction during exercise using near infrared spectroscopy.
timeFrame: 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.
measure: Endurance exercise capacity in seconds.
timeFrame: 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.
Other outcomes:
Locations:
city: Bois-Guillaume
country: France
facility: ADIR Association
Study officials:
affiliation: Normandie University, UNIROUEN, UPRES EA 3830, Haute Normandie Research and Biomedical Innovation, Rouen, France ; Pulmonary, Thoracic Oncology and Respiratory Intensive Care Department, Rouen University Hospital, Rouen, France
name: Antoine Cuvelier, MD, PhD, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: ADIR Association, Rouen University Hospital, Rouen, France ; Normandie University, UNIROUEN, UPRES EA 3830, Haute Normandie Research and Biomedical Innovation, Rouen, France
name: Jean-François Muir, MD, Prof
role: STUDY_CHAIR
affiliation: Normandie University, UNIROUEN, UPRES EA 3830, Haute Normandie Research and Biomedical Innovation, Rouen, France ; Pulmonary, Thoracic Oncology and Respiratory Intensive Care Department, Rouen University Hospital, Rouen, France
name: Maxime Patout, MD, Msc
role: STUDY_CHAIR
affiliation: UADIR Association, Rouen University Hospital, Rouen, France ; niversity, UNIROUEN, UPRES EA 3830, Haute Normandie Research and Biomedical Innovation, Rouen, France
name: Tristan Bonnevie, Msc
role: STUDY_CHAIR
affiliation: ADIR Association, Rouen University Hospital, Rouen, France ; Normandie University, UNIROUEN, UPRES EA 3830, Haute Normandie Research and Biomedical Innovation, Rouen, France
name: Francis-Edouard Gravier, Msc
role: STUDY_CHAIR
References: