High Flow Nasal Cannula During Pulmonary Rehabilitation

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Device: High Flow Nasal Cannula; Device: Nasal Cannula

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taoyuan, Taiwan, 33305
    • Linkou Chang Gung Memorial Hospital
  • Taoyuan, Taiwan, 61363
    • Chang Gung memorial hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High Flow Nasal Cannula; Patients are randomly assigned into High flow nasal cannula group for the exercise training	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.; Other Names: HFNC
Experimental: Nasal Cannula; Patients are randomly assigned into nasal cannula group for the exercise training.	Device: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chang Gung University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): July 1, 2018
• Study Completion (Actual): August 1, 2018

Study Registration Dates

• First Submitted: July 16, 2017
• First Submitted That Met QC Criteria: July 31, 2017
• First Posted (Actual): August 3, 2017

Study Record Updates

• Last Update Posted (Actual): February 25, 2019
• Last Update Submitted That Met QC Criteria: February 22, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: COPD; Pulmonary rehabilitation; Chronic Obstructive Pulmonary Disease; High flow nasal cannula; Exercise endurance; Oxygen Therapy; Nasal cannula; Pulmonary rehab
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: NMRPD1F0731

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No