High Flow Nasal Cannula During Pulmonary Rehabilitation

Study Overview
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Brief Summary
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The primary purpose of this study is to compare and assess the immediate and long-term effects on pulmonary rehabilitation training with the usage of HFNC or conventional oxygen therapy device. The hypotheses was, with high flow nasal cannula usage while exercising, the physiological outcome measurements would be better than conventional oxygen therapy device. Also, the usage of HFNC can immediately increase patient's exercising endurance and decrease dyspnea caused by exercising.

Detailed Description
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Pulmonary Rehabilitation is one of the most recommended methods to improve the muscle function of COPD patients. By exercise training, even patients with severe COPD can increase muscle strength, improve skeletal muscle function and enhance exercise endurance. Due to improvements in exercise endurance, when exercising at a higher intensity, ventilation support and dynamic hyperinflation would slightly decrease which leads to less dyspnea during exercise. Continuously exercising can also increase the motivation to exercise, reduce mood irritability and psychological burden caused by symptoms. By exercising, patient's health status can be both improved physically and mentally. High Flow Nasal Cannula (HFNC) is a non-invasive ventilatory device that provides stable oxygen concentration, temperature (37℃) and humidity (Relative Humidity: 100%). Humidity provided by the HFNC reduces irritation caused by the high flow, which leads to the increase of user's tolerance with the device. With the half-closed system formed by a nasal prong, when the high flow enters the upper airway, continue positive airway pressure would be formed. Subjects enrolled into this study are required to join a 6-week pulmonary rehabilitation program. Before starting the program, subjects were randomly assigned to high flow nasal cannula group and conventional oxygen therapy group. When exercising, the nasal cannula group would receive an oxygen flow of 3 - 5L to maintain SpO2>90% and the HFNC group with high flow setting of 45-50Lpm along with oxygen flow of 3-5L also to maintain SpO2>90%. When joining the pulmonary rehabilitation program, patients are required to exercise for approximately 45 minutes per session. When exercising, changes in the degree of dyspnea, quadriceps blood flow and hemodynamics are assessed. After 6-week of the exercise training, all the parameters will again be assessed and compared to the primary data that was collected from the beginning of the program.

Official Title
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Effectiveness of High Flow Nasal Nannula on Exercise Endurance Among Patients During Pulmonary Rehabilitation

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Device: High Flow Nasal Cannula
* Device: Nasal Cannula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 55 years COPD patients with confirmed pulmonary function test results of FEV1<70% Regular follow-up at the pulmonary medicine clinic Stable condition without acute exacerbation No pulmonary rehabilitation training within a year None oxygen usage at home No smoking history or quit smoking Inform consent signed Exclusion Criteria: Fever (Body Temperature >37.5°C) Acute infection symptoms Unstable cardiovascular status (Eg: Blood pressure >150/100 mmHg after medication usage, angina pectoris, or abnormal ECG) Activity restrictions due to orthopedic or neuromuscular disease

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Flow Nasal Cannula<br>Patients are randomly assigned into High flow nasal cannula group for the exercise training | Device: High Flow Nasal Cannula<br>* High Flow Nasal Cannula (HFNC) is an oxygen device that increases oxygenation and washes out CO2 within the dead space, it was also clinically used to correct hypoxemia, hypercapnia and respiratory failure.By providing flow rate that is similar to or higher than the patient's inspiratory flow, HFNC is able to provide ventilatory support. To produce stable oxygen concentration, HFNC entrains less air in order to reach the preset value.<br>* Other names: HFNC;|
| Experimental: Nasal Cannula<br>Patients are randomly assigned into nasal cannula group for the exercise training. | Device: Nasal Cannula<br>* Nasal cannula is an oxygen therapy device that has been commonly used as treatment for patients with hypoxemia. With the adjustable flow of 1-6Lpm, the concentration of the oxygen differs as the breathing pattern of the patient changes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac Output in L/min | Heart rate and stroke volume will be combined to report cardiac output in L/min | Changes from baseline to 6 weeks and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COPD Assessment Test (CAT) | Questionnaire designed to evaluate COPD patient's quality of life. | Changes from baseline to 6 weeks and 12 weeks | 
| Modified Medical Research Council (mMRC) Dyspnea Scale | Scale to determine the breathlessness of COPD patients during their daily activity | Changes from baseline to 6 weeks and 12 weeks | 
| The maximum inspiratory pressure in cmH2O | The maximum inspiratory pressure in cmH2O represents the strength of the abdominal and expiratory muscles | Changes from baseline to 6 weeks and 12 weeks | 
| The maximum expiratory pressure in cmH2O | The maximum expiratory pressure in cmH2O | Changes from baseline to 6 weeks and 12 weeks | 
| Tissue Saturation Index | Tissue Saturation Index measured by near-Infrared spectroscopy | Changes from baseline to 6 weeks and 12 weeks | 
| Total Hemoglobin | Total Hemoglobin measured by near-Infrared spectroscopy | Changes from baseline to 6 weeks and 12 weeks | 
| Borg Scale | Scale examining the level of dyspnea or the shortness of breath during exercise | Changes from baseline to 6 weeks and 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, High flow nasal cannula, Pulmonary rehab, Pulmonary rehabilitation, Nasal cannula, Exercise endurance, Oxygen Therapy, Chronic Obstructive Pulmonary Disease