The Effect of HFNC on Exercise Capacity Compared to VM in COPD Patients Recovering From Acute Evacerbation

October 16, 2021 updated by: Shiying Fang, The First Affiliated Hospital of Guangzhou Medical University

The Effect of High Flow Nasal Cannula on Exercise Capacity Compared to Venturi Mask in COPD Patients Recovering From Acute Evacerbation

Early PR is thought to be effective in COPD patients recovering from acute exacerbation, while the effect of HFNC during exercise training in these patients remains unclear. The study may provide evidence of early PR in COPD patients recovering from acute exacerbation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

We hypothesize that HFNC may increases exercise time in COPD patients recovering from acute exacerbation compare to VM. A randomized, cross-over clinical trial in which either HFNC or VM may be used as an adjunct in 10-MST in random order, respectively, will be performed to compare the endurance time. The physiological effect of HFNC and VM during exercise will also be measured to explore the mechanism.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • 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 Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510120

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

Ages Eligible for Study

40 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • hospitalized AECOPD patients
  • be ambulatory by 48h after admission for AECOPD
  • requires oxygen by screening exercise test

Exclusion Criteria:

  • active coronary ischemia
  • respiratory diseases other than COPD
  • unstable vital signs
  • unstable psychological status

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: HFNC group
  • Set FiO2 28%
  • Titrate the flow of HFNC at the highest tolerated value up to 60 L/min
Device: high flow nasal cannula
HFNC provides humidified, heated, oxygen-enriched air at constant concentration with a flow up to 60L/min through a nasal cannula. It washouts the anatomical dead space and decreases the work of breathing.
ACTIVE_COMPARATOR: VM group
- Keep FiO2 constant with VM and HFNC during the two trial
Device: Venturi mask
VM is commonly used by COPD patients during exercise training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endurance time
Time Frame: 10 minute
Endurance time for 10 minute steping test
10 minute

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory pattern
Time Frame: 10 minute
Respiratory pattern is calculated by the flow and time
10 minute
Work of breathing
Time Frame: 10 minute
Work of breathing is calculated by the transdiaphragmatic pressure
10 minute
Neural respiratory drive
Time Frame: 10 minute
Neural respiratory drive is calculated by diaphragm electromyogram
10 minute

Collaborators and Investigators

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

Sponsor

The First Affiliated Hospital of Guangzhou Medical 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)

August 11, 2021

Primary Completion (ANTICIPATED)

May 31, 2022

Study Completion (ANTICIPATED)

August 31, 2022

Study Registration Dates

First Submitted

October 16, 2021

First Submitted That Met QC Criteria

October 16, 2021

First Posted (ACTUAL)

October 28, 2021

Study Record Updates

Last Update Posted (ACTUAL)

October 28, 2021

Last Update Submitted That Met QC Criteria

October 16, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FAHGZ-20210811

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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