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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Flow Nasal Cannula | Experimental | Patients are randomly assigned into High flow nasal cannula group for the exercise training |
|
| Nasal Cannula | Experimental | Patients are randomly assigned into nasal cannula group for the exercise training. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Flow Nasal Cannula | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hui-Ling Lin, MSc | Chang Gung University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Linkou Chang Gung Memorial Hospital | Taoyuan | 33305 | Taiwan | |||
| Chang Gung Memorial Hospital |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 29, 2020 | |
| Reset | Feb 7, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 29, 2020 | Feb 7, 2020 |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D000072601 | Cannula |
| ID | Term |
|---|---|
| D057785 | Catheters |
| D004864 | Equipment and Supplies |
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|
|
| Nasal Cannula | Device | 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. |
|
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 |
| Taoyuan |
| 61363 |
| Taiwan |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |