High Flow Nasal Cannula During Pulmonary Rehabilitation

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03237962
• Other study ID #: NMRPD1F0731
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: August 2018

Study information

• Verified date: February 2019
• Source: Chang Gung University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• High Flow Nasal Cannula
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.
• Nasal Cannula
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.

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Taoyuan
Taiwan	Linkou Chang Gung Memorial Hospital	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	COPD Assessment Test (CAT)	Questionnaire designed to evaluate COPD patient's quality of life.	Changes from baseline to 6 weeks and 12 weeks
Secondary	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
Secondary	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
Secondary	The maximum expiratory pressure in cmH2O	The maximum expiratory pressure in cmH2O	Changes from baseline to 6 weeks and 12 weeks
Secondary	Tissue Saturation Index	Tissue Saturation Index measured by near-Infrared spectroscopy	Changes from baseline to 6 weeks and 12 weeks
Secondary	Total Hemoglobin	Total Hemoglobin measured by near-Infrared spectroscopy	Changes from baseline to 6 weeks and 12 weeks
Secondary	Borg Scale	Scale examining the level of dyspnea or the shortness of breath during exercise	Changes from baseline to 6 weeks and 12 weeks