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

NCT04014868 | Completed

• 1 other identifier: AIRVO-PHYSIO
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic obstructive pulmonary disease; Exercise; Nasal high flow; Muscle

Outcome Measures

Primary Outcomes (1)

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

  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).

  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 (8)

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

  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 using indirect calorimetry

  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.

• Dynamic hyperinflation using the fall in during-exercise inspiratory capacity

  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.

• Transcutaneous arterial carbon dioxide partial pressure using capnography.

  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.

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

  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.

Study Arms (2)

Nasal high-flow

EXPERIMENTAL

Patients will perform a constant workload exercise testing (75% of the maximal workload achieved during a previously performed incremental cardiopulmonary exercise testing) with active nasal high-flow : Flow : 30 L/min; Temperature : 34°C; The device will be out of sight of the patient. The device allow for oxygen supplementation (fitting on the back of the device). Usual oxygen prescription (if any) will be adjusted to reach a transcutaneous oxygen saturation superior to 90%. A second fitting will be placed just before the nasal canula to allow for oxygen supplementation during the sham nasal high-flow (device turned OFF) test. Due to the cross-over design of the study, all patients will perform both interventions.

Device: Nasal high-flow

Sham nasal high-flow

SHAM COMPARATOR

Patients will perform a constant workload exercise testing (75% of the maximal workload achieved during a previously performed incremental cardiopulmonary exercise testing) with a sham nasal high-flow : The procedure will be exactly the same but the device (out of sight of the patient) will be turned OFF. Oxygen supplementation will be possible through the fitting placed just before the nasal canula. Due to the cross-over design of the study, all patients will perform both interventions.

Other: Sham nasal high-flow

Interventions

Nasal high-flow DEVICE

See arm description.

Nasal high-flow

Sham nasal high-flow OTHER

See arm description.

Sham nasal high-flow

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Tracheostomy;
• Nasal high flow intolerance;
• Pregnancy or likely to be;
• Unable to consent;
• Patients under guardianship.

Sponsors & Collaborators

• ADIR Association: lead

Study Sites (1)

ADIR Association

Bois-Guillaume, 76230, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• Antoine Cuvelier, MD, PhD, Prof

  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

  PRINCIPAL INVESTIGATOR

• Jean-François Muir, MD, Prof

  ADIR Association, Rouen University Hospital, Rouen, France ; Normandie University, UNIROUEN, UPRES EA 3830, Haute Normandie Research and Biomedical Innovation, Rouen, France

  STUDY CHAIR

• Maxime Patout, MD, Msc

  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

  STUDY CHAIR

• Tristan Bonnevie, Msc

  UADIR Association, Rouen University Hospital, Rouen, France ; niversity, UNIROUEN, UPRES EA 3830, Haute Normandie Research and Biomedical Innovation, Rouen, France

  STUDY CHAIR

• Francis-Edouard Gravier, Msc

  ADIR Association, Rouen University Hospital, Rouen, France ; Normandie University, UNIROUEN, UPRES EA 3830, Haute Normandie Research and Biomedical Innovation, Rouen, France

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The nasal high-flow device will be out of sight of the patients and will not be switched ON. The oxygen connection at the exit of the device will be obstructed. If the patient needs supplementary oxygen during-exercise, it will be provided through the fitting located just before the nasal canula (see Arms, Experimental: Nasal high-flow).
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-blind randomized cross-over study.

Study Record Dates

• First Submitted: July 8, 2019
• First Posted: July 10, 2019
• Study Start: November 22, 2019
• Primary Completion: October 1, 2021
• Study Completion: October 10, 2021
• Last Updated: March 17, 2022

Record last verified: 2022-03

Locations

FR (1)