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Status unknownNCT05097560Updated Oct 28, 2021

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

An interventional study of high flow nasal cannula and Venturi mask in COPD, sponsored by The First Affiliated Hospital of Guangzhou Medical University. Status unknown at 1 site in China. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-10-28.

Sponsored by The First Affiliated Hospital of Guangzhou Medical University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • COPD

Keywords

  • HFNC
  • PR
03

In context

Lead sponsor

The First Affiliated Hospital of Guangzhou Medical University is the lead sponsor of 158 studies on the registry; 65 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • 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

  • Active comparator
    VM group

    - Keep FiO2 constant with VM and HFNC during the two trial

    Device: Venturi mask

Interventions

  • Devicehigh 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.

  • DeviceVenturi mask

    VM is commonly used by COPD patients during exercise training.

06

What researchers measure

Primary outcomes

  1. Endurance time

    Endurance time for 10 minute steping test

    Time frame: 10 minute

Secondary outcomes

  1. Respiratory pattern

    Respiratory pattern is calculated by the flow and time

    Time frame: 10 minute

  2. Work of breathing

    Work of breathing is calculated by the transdiaphragmatic pressure

    Time frame: 10 minute

  3. Neural respiratory drive

    Neural respiratory drive is calculated by diaphragm electromyogram

    Time frame: 10 minute

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 28, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05097560
Lead sponsor
The First Affiliated Hospital of Guangzhou Medical University
Responsible party
Shiying Fang (Principal Investigator, The First Affiliated Hospital of Guangzhou Medical University) — Principal investigator
First posted
Oct 28, 2021
Start date
Aug 11, 2021
Primary completion
May 31, 2022 (estimated)
Completion
Aug 31, 2022 (estimated)
Last update
Oct 28, 2021

Study contacts

Shiying Fang, MD
Contact
fangshiying2019@126.com
+8602083062882
Rongchang Chen, PhD
study chair · The First Affiliated Hospital of Guangzhou Medical University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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