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OpenTrials
Completed

NCT Number: NCT05130112

Impact of Airways Function After HFNC Evaluated by IOS

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.

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Key information

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yen-Liang Kuo

New Taipei City, 24205, Taiwan

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

high flow nasal cannula and nasal cannula

Device

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.

Primary outcomes

  1. R5

    Time frame: immediately after 10 minutes of HFNC or NC

    Changes of R5

  2. R5%

    Time frame: immediately after 10 minutes of HFNC or NC

    Changes of R5%

  3. R20

    Time frame: immediately after 10 minutes of HFNC or NC

    Changes of R20

  4. R20%

    Time frame: immediately after 10 minutes of HFNC or NC

    Changes of R20%

  5. Changes of R5-20

    Time frame: immediately after 10 minutes of HFNC or NC

    R5-20

  6. X5-predicted

    Time frame: immediately after 10 minutes of HFNC or NC

    Changes of X5-predicted

  7. X5-predicted%

    Time frame: immediately after 10 minutes of HFNC or NC

    Changes of X5-predicted%

  8. Changes of Fres

    Time frame: immediately after 10 minutes of HFNC or NC

    Fres

  9. Changes of Fres%

    Time frame: immediately after 10 minutes of HFNC or NC

    Fres%

  10. Changes of Ax

    Time frame: immediately after 10 minutes of HFNC or NC

    Ax

  11. Ax%

    Time frame: immediately after 10 minutes of HFNC or NC

    Changes of Ax%

Secondary outcomes

  1. TcPCO2

    Time frame: immediately after 10 minutes of HFNC or NC

    Changes of TcPCO2

  2. Body temperature

    Time frame: immediately after 10 minutes of HFNC or NC

    Changes of body temperature

  3. pulse rate

    Time frame: immediately after 10 minutes of HFNC or NC

    Changes of pulse rate

  4. respiratory rate

    Time frame: immediately after 10 minutes of HFNC or NC

    Changes of respiratory rate

  5. both systolic and diastolic blood pressure

    Time frame: immediately after 10 minutes of HFNC or NC

    Changes of both systolic and diastolic blood pressure

  6. SpO2

    Time frame: immediately after 10 minutes of HFNC or NC

    Changes of SpO2

  7. FEV1

    Time frame: immediately after 10 minutes of HFNC or NC

    Changes of FEV1

  8. FEV1%

    Time frame: immediately after 10 minutes of HFNC or NC

    Changes of FEV1%

  9. FVC

    Time frame: immediately after 10 minutes of HFNC or NC

    Changes of FVC

  10. FVC%

    Time frame: immediately after 10 minutes of HFNC or NC

    Changes of FVC%

  11. FEV1/FVC%

    Time frame: immediately after 10 minutes of HFNC or NC

    Changes of FEV1/FVC%

  12. Changes of FEV3

    Time frame: immediately after 10 minutes of HFNC or NC

    FEV3

  13. FEV3%

    Time frame: immediately after 10 minutes of HFNC or NC

    Changes of FEV3%

  14. FEV3/FVC%

    Time frame: immediately after 10 minutes of HFNC or NC

    Changes of FEV3/FVC%

  15. MMEF

    Time frame: immediately after 10 minutes of HFNC or NC

    Changes of MMEF

  16. Changes of MMEF%

    Time frame: immediately after 10 minutes of HFNC or NC

    MMEF%

  17. PEF

    Time frame: immediately after 10 minutes of HFNC or NC

    Changes of PEF

  18. PEF%

    Time frame: immediately after 10 minutes of HFNC or NC

    Changes of PEF%

Sponsors and collaborators

Lead sponsor

Fu Jen Catholic University Hospital

Other

Registry information

Official study title

Impact of Airways Function After Short-term Use of High-flow Nasal Cannula Gas Therapy Evaluated by Impulse Oscillometry Systems in Stable Chronic Obstructive Pulmonary Disease Patients

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 22, 2021
Registry last updated
Nov 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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