NCT03237962

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Aug 2016

Typical duration for not_applicable chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2017

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 3, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

February 25, 2019

Status Verified

February 1, 2019

Enrollment Period

1.9 years

First QC Date

July 16, 2017

Last Update Submit

February 22, 2019

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

High flow nasal cannulaPulmonary rehabPulmonary rehabilitationNasal cannulaExercise enduranceOxygen TherapyCOPDChronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • COPD Assessment Test (CAT)

    Changes from baseline to 6 weeks and 12 weeks

  • Modified Medical Research Council (mMRC) Dyspnea Scale

    Changes from baseline to 6 weeks and 12 weeks

  • The maximum inspiratory pressure in cmH2O

    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

    Changes from baseline to 6 weeks and 12 weeks

  • +2 more secondary outcomes

Study Arms (2)

High Flow Nasal Cannula

EXPERIMENTAL

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

Device: High Flow Nasal Cannula

Nasal Cannula

EXPERIMENTAL

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

Device: Nasal Cannula

Interventions

High Flow Nasal CannulaDEVICE

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.

Also known as: HFNC
High Flow Nasal Cannula
Nasal CannulaDEVICE

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.

Nasal Cannula

Eligibility Criteria

Age55 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Linkou Chang Gung Memorial Hospital

Taoyuan District, 33305, Taiwan

Location

Chang Gung Memorial Hospital

Taoyuan District, 61363, Taiwan

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Cannula

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CathetersEquipment and Supplies

Study Officials

  • Hui-Ling Lin, MSc

    Chang Gung University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Proffesor

Study Record Dates

First Submitted

July 16, 2017

First Posted

August 3, 2017

Study Start

August 1, 2016

Primary Completion

July 1, 2018

Study Completion

August 1, 2018

Last Updated

February 25, 2019

Record last verified: 2019-02

Locations

TW(2)