Nasal High Flow to Maintain the Benefits of Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease Patients

NCT ID: NCT03882372

Last Updated: 2023-11-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-22
• Study Completion Date: 2023-09-01

Brief Summary

Chronic obstructive pulmonary disease (COPD) is a major cause of disability and mortality worldwide. This systemic disease progressively leads to dyspnea and exercise capacity impairment. Pulmonary rehabilitation effectively improves exercise capacity, dyspnea and quality of life in patients with COPD. However, its benefits progressively fade over time due to several factors such as the lack of regular exercise activity, dyspnea, airway secretions, hematosis impairment and acute exacerbations which can lead to hospitalization and accelerated muscle wasting.

Nasal high flow (NHF) is a support used to deliver heated and humidified high flow air (up to 60 L/min) through nasal canula providing promising physiological benefits such as positive airway pressure or upper airway 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, several studies have shown that long-term nasal high flow could contribute to improve exercise capacity, dyspnea, airway secretion removal, hematosis, reduced acute exacerbations and subsequent hospitalizations in patients with COPD.

Based on these results, the primary aim of this study is to assess whether long-term nasal high flow treatment can help COPD patients to better maintain their endurance capacity following a course of pulmonary rehabilitation.

Detailed Description

Experimental design:

Patients achieving their last pulmonary rehabilitation session will be approached to participate in this study.

Eligible patients who agree to participate in the study and sign informed consent will perform two baseline visit assessments:

First visit: Incremental cardiopulmonary exercise testing. Second visit: Other baseline assessment (see outcome section), including a constant workload exercise testing at 75% of the maximal workload achieved during the incremental exercise testing.

Then, patients will then be randomized to one of the following two arms:

• Nasal high flow,
• Usual care.

After 6 months, patients will be invited to perform the same assessment as during the second baseline visit.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

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

Study Groups

Nasal high flow

Following baseline assessment, patients randomized to the nasal high flow arm will be equipped with a nasal high flow device (myAIRVO2) administrated through the Optiflow nasal canula. Flow will be set at the highest flow tolerated (20-30 L/min): initially 30 L/min, progressively decrease if not tolerated. Temperature will be set between 34-37°C according to the tolerance : initially 37°C and decreased if not tolerated. Patients will be asked to use the device 8h per day.

Patients under long-term oxygen will preserve their usual flow. The usual prescribed oxygen flow will then be titrated during nasal high flow to maintain the same baseline transcutaneous oxygen saturation as their conventional oxygen therapy (≥ 90%) to prevent any oxygen dilution effect of nasal high flow.

Group Type: EXPERIMENTAL

Nasal high flow

Intervention Type: DEVICE

See arm description.

Usual care

Patient randomized to the control group will have no other specific intervention than their usual care.

Patients under long-term oxygen will preserve their usual flow.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Nasal high flow

See arm description.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Chronic obstructive pulmonary disease stage III to IV;
• With or without long-term oxygen therapy;
• Having completed a course of pulmonary rehabilitation within the last 4 weeks (at least 18 sessions).

Exclusion Criteria

• Did not complete a course of pulmonary rehabilitation;
• Using noninvasive ventilation or constant positive airway pressure treatment;
• 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

ADIR Association, Rouen University Hospital, Rouen, France ; Normandie University, 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 ; Pulmonary, Thoracic Oncology and Respiratory I

Locations

ADIR Association

Bois-Guillaume, , France

Countries

France

Other Identifiers

PPR-NHF

Identifier Type: -

Identifier Source: org_study_id