High Flow Nasal Cannula During Pulmonary Rehabilitation

February 22, 2019 updated by: Hui-Ling Lin, Chang Gung University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cardiac Output in L/min
Time Frame: Changes from baseline to 6 weeks and 12 weeks
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
COPD Assessment Test (CAT)
Time Frame: Changes from baseline to 6 weeks and 12 weeks
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
Time Frame: Changes from baseline to 6 weeks and 12 weeks
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
Time Frame: Changes from baseline to 6 weeks and 12 weeks
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
Time Frame: Changes from baseline to 6 weeks and 12 weeks
The maximum expiratory pressure in cmH2O
Changes from baseline to 6 weeks and 12 weeks
Tissue Saturation Index
Time Frame: Changes from baseline to 6 weeks and 12 weeks
Tissue Saturation Index measured by near-Infrared spectroscopy
Changes from baseline to 6 weeks and 12 weeks
Total Hemoglobin
Time Frame: Changes from baseline to 6 weeks and 12 weeks
Total Hemoglobin measured by near-Infrared spectroscopy
Changes from baseline to 6 weeks and 12 weeks
Borg Scale
Time Frame: Changes from baseline to 6 weeks and 12 weeks
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chang Gung University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 16, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 3, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 25, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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