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CompletedNCT05130112Updated Nov 22, 2021

Impact of Airways Function After HFNC Evaluated by IOS

An interventional study of high flow nasal cannula and nasal cannula in Small Airway Disorders and COPD, sponsored by Fu Jen Catholic University Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-11-22.

Sponsored by Fu Jen Catholic University Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Mar 2020, 6 years 6 months ago, and no results have been posted to the registry.
  • Registered 1 year 9 months after the study started (first participant enrolled Dec 2019, registered Oct 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
20 Years to 75 Years
Sex
All
01

Study summary

In addition to pharmacological treatment, nonpharmacological treatment with high-flow nasal cannula (HFNC) may play a vital role in the treatment of patients with chronic obstructive pulmonary disease (COPD). The impulse oscillation system (IOS) is new noninvasive technique to measure the impedance of different portions of the airway with higher sensitivity than that of the conventional pulmonary function test (PFT). However, whether IOS is an appropriate technique to evaluate the efficacy of HFNC in improving the impedance of peripheral small airways in patients with COPD is unclear.

Read the detailed description

Participants with stable COPD from the chest medicine outpatient department will be randomized into two groups receiving HFNC or nasal cannula (NC) for 10 min followed by a 4-week washout period and crossover alternatively. We used a novel analytical measurement technique, IOS, to detect the difference in airway impedance in the participants after the HFNC or NC interventions. All data, namely IOS parameters, transcutaneous partial pressure of carbon dioxide, peripheral oxygen saturation, body temperature, respiratory rate, pulse rate, blood pressure, and PFT results at the time of pre-HFNC, post-HFNC, pre-NC, and post-NC, were analysed using SPSS (version 25.0, IBM, Armonk, NY, USA).

02

Conditions studied

  • Small Airway Disorders
  • COPD

Keywords

  • high-flow nasal cannula
  • high nasal flow
  • chronic obstructive pulmonary disease (COPD)
  • airway impedance
  • distal airway
  • peripheral airway
  • airway resistance
03

In context

Lead sponsor

Fu Jen Catholic University Hospital is the lead sponsor of 30 studies on the registry; 15 are open to participants now.

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

04

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • age of 20 to 75 years old
  • diagnosis of COPD made by pulmonologist (Kuo YL) if the patient had a long-term smoking or noxious gas exposure history, typical clinical manifestations, and airflow limitation with a postbronchodilator FEV1/FVC ratio of \< 0.7 in spirometry,4 and
  • provision of written informed consent.

Exclusion criteria

Exclusion Criteria:

  • severe and unstable comorbidities or active malignancy
  • history of obstructive sleep apnoea syndrome
  • COPD exacerbation within the 4 weeks prior
  • current use of long-term oxygen therapy or noninvasive ventilation or use within the 6 weeks prior
  • cognitive impairment or a psychiatric disorder
  • pregnancy
05

Study design

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

Study arms

  • Experimental
    HFNC then NC

    High flow nasal cannula for 10 min (Period 1) and nasal cannula for 10 min (Period 2) after a 4-week washout period

    Device: high flow nasal cannula and nasal cannula

  • Experimental
    NC then HFNC

    Nasal cannula for 10 min (Period 1) and high flow nasal cannula for 10 min (Period 2) after a 4-week washout period

    Device: high flow nasal cannula and nasal cannula

Interventions

  • Devicehigh flow nasal cannula and nasal cannula

    HFNC was administered using the MyAIRVO 2 device (Fisher \& Paykel Healthcare, Auckland, New Zealand), which provides humidification and high-flow medical gas through an Optiflow NC interface (Fisher \& Paykel Healthcare, Auckland, New Zealand) is administered for 10 min.. NC is administered for 10 min.

06

What researchers measure

Primary outcomes

  1. R5

    Changes of R5

    Time frame: immediately after 10 minutes of HFNC or NC

  2. R5%

    Changes of R5%

    Time frame: immediately after 10 minutes of HFNC or NC

  3. R20

    Changes of R20

    Time frame: immediately after 10 minutes of HFNC or NC

  4. R20%

    Changes of R20%

    Time frame: immediately after 10 minutes of HFNC or NC

  5. Changes of R5-20

    R5-20

    Time frame: immediately after 10 minutes of HFNC or NC

  6. X5-predicted

    Changes of X5-predicted

    Time frame: immediately after 10 minutes of HFNC or NC

  7. X5-predicted%

    Changes of X5-predicted%

    Time frame: immediately after 10 minutes of HFNC or NC

  8. Changes of Fres

    Fres

    Time frame: immediately after 10 minutes of HFNC or NC

  9. Changes of Fres%

    Fres%

    Time frame: immediately after 10 minutes of HFNC or NC

  10. Changes of Ax

    Ax

    Time frame: immediately after 10 minutes of HFNC or NC

  11. Ax%

    Changes of Ax%

    Time frame: immediately after 10 minutes of HFNC or NC

Secondary outcomes

  1. TcPCO2

    Changes of TcPCO2

    Time frame: immediately after 10 minutes of HFNC or NC

  2. Body temperature

    Changes of body temperature

    Time frame: immediately after 10 minutes of HFNC or NC

  3. pulse rate

    Changes of pulse rate

    Time frame: immediately after 10 minutes of HFNC or NC

  4. respiratory rate

    Changes of respiratory rate

    Time frame: immediately after 10 minutes of HFNC or NC

  5. both systolic and diastolic blood pressure

    Changes of both systolic and diastolic blood pressure

    Time frame: immediately after 10 minutes of HFNC or NC

  6. SpO2

    Changes of SpO2

    Time frame: immediately after 10 minutes of HFNC or NC

  7. FEV1

    Changes of FEV1

    Time frame: immediately after 10 minutes of HFNC or NC

  8. FEV1%

    Changes of FEV1%

    Time frame: immediately after 10 minutes of HFNC or NC

  9. FVC

    Changes of FVC

    Time frame: immediately after 10 minutes of HFNC or NC

  10. FVC%

    Changes of FVC%

    Time frame: immediately after 10 minutes of HFNC or NC

  11. FEV1/FVC%

    Changes of FEV1/FVC%

    Time frame: immediately after 10 minutes of HFNC or NC

  12. Changes of FEV3

    FEV3

    Time frame: immediately after 10 minutes of HFNC or NC

  13. FEV3%

    Changes of FEV3%

    Time frame: immediately after 10 minutes of HFNC or NC

  14. FEV3/FVC%

    Changes of FEV3/FVC%

    Time frame: immediately after 10 minutes of HFNC or NC

  15. MMEF

    Changes of MMEF

    Time frame: immediately after 10 minutes of HFNC or NC

  16. Changes of MMEF%

    MMEF%

    Time frame: immediately after 10 minutes of HFNC or NC

  17. PEF

    Changes of PEF

    Time frame: immediately after 10 minutes of HFNC or NC

  18. PEF%

    Changes of PEF%

    Time frame: immediately after 10 minutes of HFNC or NC

07

Study locations

1 site
  • Yen-Liang Kuo
    New Taipei City, 24205, Taiwan
08

References and documents

Publications

  • Kuo YL, Chien CL, Ko HK, Lai HC, Lin TL, Lee LN, Chang CY, Shen HS, Lu CC. High-flow nasal cannula improves respiratory impedance evaluated by impulse oscillometry in chronic obstructive pulmonary disease patients: a randomised controlled trial. Sci Rep. 2022 Apr 28;12(1):6981. doi: 10.1038/s41598-022-10873-x. PubMed 35484186 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 22, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05130112
Lead sponsor
Fu Jen Catholic University Hospital
Responsible party
Sponsor
First posted
Nov 22, 2021
Start date
Dec 13, 2019
Primary completion
Mar 31, 2020
Completion
Sep 9, 2020
Last update
Nov 22, 2021

Study contacts

Yen-Liang Kuo, MD
principal investigator · Fu Jen Catholic University Hospital

Oversight

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

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

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