search
Back to results

High Flow Nasal Cannula During Pulmonary Rehabilitation

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
High Flow Nasal Cannula
Nasal Cannula
Sponsored by
Chang Gung University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Obstructive Pulmonary Disease focused on measuring High flow nasal cannula, Pulmonary rehab, Pulmonary rehabilitation, Nasal cannula, Exercise endurance, Oxygen Therapy, COPD, Chronic Obstructive Pulmonary Disease

Eligibility Criteria

55 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Linkou Chang Gung Memorial Hospital
  • Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

High Flow Nasal Cannula

Nasal Cannula

Arm Description

Patients are randomly assigned into High flow nasal cannula group for the exercise training

Patients are randomly assigned into nasal cannula group for the exercise training.

Outcomes

Primary Outcome Measures

Cardiac Output in L/min
Heart rate and stroke volume will be combined to report cardiac output in L/min

Secondary Outcome Measures

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

Full Information

First Posted
July 16, 2017
Last Updated
February 22, 2019
Sponsor
Chang Gung University
search

1. Study Identification

Unique Protocol Identification Number
NCT03237962
Brief Title
High Flow Nasal Cannula During Pulmonary Rehabilitation
Official Title
Effectiveness of High Flow Nasal Nannula on Exercise Endurance Among Patients During Pulmonary Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
High flow nasal cannula, Pulmonary rehab, Pulmonary rehabilitation, Nasal cannula, Exercise endurance, Oxygen Therapy, COPD, Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Flow Nasal Cannula
Arm Type
Experimental
Arm Description
Patients are randomly assigned into High flow nasal cannula group for the exercise training
Arm Title
Nasal Cannula
Arm Type
Experimental
Arm Description
Patients are randomly assigned into nasal cannula group for the exercise training.
Intervention Type
Device
Intervention Name(s)
High Flow Nasal Cannula
Other Intervention Name(s)
HFNC
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Nasal Cannula
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cardiac Output in L/min
Description
Heart rate and stroke volume will be combined to report cardiac output in L/min
Time Frame
Changes from baseline to 6 weeks and 12 weeks
Secondary Outcome Measure Information:
Title
COPD Assessment Test (CAT)
Description
Questionnaire designed to evaluate COPD patient's quality of life.
Time Frame
Changes from baseline to 6 weeks and 12 weeks
Title
Modified Medical Research Council (mMRC) Dyspnea Scale
Description
Scale to determine the breathlessness of COPD patients during their daily activity
Time Frame
Changes from baseline to 6 weeks and 12 weeks
Title
The maximum inspiratory pressure in cmH2O
Description
The maximum inspiratory pressure in cmH2O represents the strength of the abdominal and expiratory muscles
Time Frame
Changes from baseline to 6 weeks and 12 weeks
Title
The maximum expiratory pressure in cmH2O
Description
The maximum expiratory pressure in cmH2O
Time Frame
Changes from baseline to 6 weeks and 12 weeks
Title
Tissue Saturation Index
Description
Tissue Saturation Index measured by near-Infrared spectroscopy
Time Frame
Changes from baseline to 6 weeks and 12 weeks
Title
Total Hemoglobin
Description
Total Hemoglobin measured by near-Infrared spectroscopy
Time Frame
Changes from baseline to 6 weeks and 12 weeks
Title
Borg Scale
Description
Scale examining the level of dyspnea or the shortness of breath during exercise
Time Frame
Changes from baseline to 6 weeks and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui-Ling Lin, MSc
Organizational Affiliation
Chang Gung University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Linkou Chang Gung Memorial Hospital
City
Taoyuan
ZIP/Postal Code
33305
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital
City
Taoyuan
ZIP/Postal Code
61363
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

High Flow Nasal Cannula During Pulmonary Rehabilitation

We'll reach out to this number within 24 hrs