NCT03883256

Brief Summary

Ventilation limitation has a significant adverse effects on cardiovascular function and cerebral oxygenation during exercise in patients with COPD. High flow nasal cannula (HFNC) has been shown to improve ventilation by washing out the anatomical dead space and permitting a better gas exchanges. Moreover, it is able to ensure the desired inspired oxygen fraction (FiO2) even at high level of patient's minute ventilation by minimizing the room air entrainment. The effects of HFNC on exercise performance in terms of hemodynamic changes and exercise endurance in COPD patients remain unclear. The primary purpose of this study is to examine the effects of HFNC on the exercise endurance in COPD patients. The investigator's secondary purpose is to investigate whether HFNC could improve efficiency of ventilation, leading to an improvement of hemodynamic and cerebral oxygenation response.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 25, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 20, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2019

Completed
Last Updated

February 4, 2021

Status Verified

February 1, 2021

Enrollment Period

1.5 years

First QC Date

March 10, 2019

Last Update Submit

February 2, 2021

Conditions

COPD

Keywords

High flow nasal cannula oxygenexercise performanceCOPD

Outcome Measures

Primary Outcomes (2)

  • exercise time with high flow nasal cannula

    the total duration that subjects performed constant-load exercise test with high flow nasal cannula oxygen device

    end of the exercise test in the session of constant-load exercise test with high flow nasal cannula oxygen device

  • exercise time with nasal cannula

    the total duration that subjects performed constant-load exercise test with nasal cannula oxygen device

    end of the exercise test in the session of constant-load exercise test with nasal cannula oxygen device

Secondary Outcomes (4)

  • Difference in cardiac output

    Baseline and 48 hours after baseline ]

  • Difference in stroke volume

    Baseline and 48 hours after baseline ]

  • Difference in muscle tissue oxygenation

    Baseline and 48 hours after baseline ]

  • Difference in cerebral tissue oxygenation

    Baseline and 48 hours after baseline ]

Study Arms (2)

high flow nasal cannula

ACTIVE COMPARATOR

Subjects perform a constant-load exercise test with high flow nasal cannula oxygen device.

Device: high flow nasal cannula

nasal cannula

ACTIVE COMPARATOR

Subjects perform a constant-load exercise test with nasal cannula oxygen device.

Device: nasal cannula

Interventions

high flow nasal cannulaDEVICE

High flow nasal cannula is a device that delivered heated and humidified high flow gases to at or near body temperature to avoid drying and possible injury to the nasal mucosa. In this study, subjects perform a constant-load exercise test with high flow nasal cannula.

high flow nasal cannula
nasal cannulaDEVICE

Nasal cannula is a device that delivered oxygen to patients. In this study, subjects perform a constant-load exercise test with nasal cannula.

nasal cannula

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • with diagnosis of COPD
  • OPD patients
  • has no AE (within 1 month)
  • not receiving any O2 therapy at home
  • no smoking or quick

You may not qualify if:

  • fever
  • unstable hemodynamics at resting
  • orthopadeic or neurologic problems that limited exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung University

Taoyuan, 333, 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

  • Yen-Huey Chen

    Chang Gung University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

March 10, 2019

First Posted

March 20, 2019

Study Start

May 25, 2018

Primary Completion

November 30, 2019

Study Completion

November 30, 2019

Last Updated

February 4, 2021

Record last verified: 2021-02

Locations

TW(1)