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

NCT ID: NCT04014868

Last Updated: 2022-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-22
• Study Completion Date: 2021-10-10

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.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Nasal high-flow

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.

Group Type: EXPERIMENTAL

Nasal high-flow

Intervention Type: DEVICE

See arm description.

Sham nasal high-flow

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.

Group Type: SHAM_COMPARATOR

Sham nasal high-flow

Intervention Type: OTHER

See arm description.

Interventions

Nasal high-flow

See arm description.

Intervention Type: DEVICE

Sham nasal high-flow

See arm description.

Intervention Type: OTHER

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).

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ADIR Association

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antoine Cuvelier, MD, PhD, Prof

Role: PRINCIPAL_INVESTIGATOR

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

Jean-François Muir, MD, Prof

Role: STUDY_CHAIR

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

Maxime Patout, MD, Msc

Role: STUDY_CHAIR

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

Tristan Bonnevie, Msc

Role: STUDY_CHAIR

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

Francis-Edouard Gravier, Msc

Role: STUDY_CHAIR

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

Locations

ADIR Association

Bois-Guillaume, , France

Countries

France

Other Identifiers

AIRVO-PHYSIO

Identifier Type: -

Identifier Source: org_study_id