Small Airway DisordersNCT05130112
Impact of Airways Function After HFNC Evaluated by IOS
A study testing high flow nasal cannula and nasal cannula in people with Small Airway Disorders and COPD, run by Fu Jen Catholic University Hospital at 1 site in Taiwan.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Small Airway Disorders, COPD
- What is being tested?
- high flow nasal cannula and nasal cannula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteTaiwan
- Study dates
- 13 Dec 2019to 9 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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).
- Conditions
- Small Airway Disorders, COPD
- Being tested
- high flow nasal cannula and nasal cannula
- Keywords
- high-flow nasal cannula, high nasal flow, chronic obstructive pulmonary disease (COPD), airway impedance, distal airway, peripheral airway, airway resistance
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high flow nasal cannula and nasal cannulaDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| HFNC then NC | Experimental | High flow nasal cannula for 10 min (Period 1) and nasal cannula for 10 min (Period 2) after a 4-week washout period Receives: Device: high flow nasal cannula and nasal cannula |
| NC then HFNC | Experimental | Nasal cannula for 10 min (Period 1) and high flow nasal cannula for 10 min (Period 2) after a 4-week washout period Receives: Device: high flow nasal cannula and nasal cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
R5
Changes of R5
Measured: immediately after 10 minutes of HFNC or NC
R5%
Changes of R5%
Measured: immediately after 10 minutes of HFNC or NC
R20
Changes of R20
Measured: immediately after 10 minutes of HFNC or NC
R20%
Changes of R20%
Measured: immediately after 10 minutes of HFNC or NC
Changes of R5-20
R5-20
Measured: immediately after 10 minutes of HFNC or NC
X5-predicted
Changes of X5-predicted
Measured: immediately after 10 minutes of HFNC or NC
X5-predicted%
Changes of X5-predicted%
Measured: immediately after 10 minutes of HFNC or NC
Changes of Fres
Fres
Measured: immediately after 10 minutes of HFNC or NC
Changes of Fres%
Fres%
Measured: immediately after 10 minutes of HFNC or NC
Changes of Ax
Ax
Measured: immediately after 10 minutes of HFNC or NC
Ax%
Changes of Ax%
Measured: immediately after 10 minutes of HFNC or NC
Secondary outcomes (18)
TcPCO2
Changes of TcPCO2
Measured: immediately after 10 minutes of HFNC or NC
Body temperature
Changes of body temperature
Measured: immediately after 10 minutes of HFNC or NC
pulse rate
Changes of pulse rate
Measured: immediately after 10 minutes of HFNC or NC
respiratory rate
Changes of respiratory rate
Measured: immediately after 10 minutes of HFNC or NC
both systolic and diastolic blood pressure
Changes of both systolic and diastolic blood pressure
Measured: immediately after 10 minutes of HFNC or NC
SpO2
Changes of SpO2
Measured: immediately after 10 minutes of HFNC or NC
FEV1
Changes of FEV1
Measured: immediately after 10 minutes of HFNC or NC
FEV1%
Changes of FEV1%
Measured: immediately after 10 minutes of HFNC or NC
FVC
Changes of FVC
Measured: immediately after 10 minutes of HFNC or NC
FVC%
Changes of FVC%
Measured: immediately after 10 minutes of HFNC or NC
FEV1/FVC%
Changes of FEV1/FVC%
Measured: immediately after 10 minutes of HFNC or NC
Changes of FEV3
FEV3
Measured: immediately after 10 minutes of HFNC or NC
FEV3%
Changes of FEV3%
Measured: immediately after 10 minutes of HFNC or NC
FEV3/FVC%
Changes of FEV3/FVC%
Measured: immediately after 10 minutes of HFNC or NC
MMEF
Changes of MMEF
Measured: immediately after 10 minutes of HFNC or NC
Changes of MMEF%
MMEF%
Measured: immediately after 10 minutes of HFNC or NC
PEF
Changes of PEF
Measured: immediately after 10 minutes of HFNC or NC
PEF%
Changes of PEF%
Measured: immediately after 10 minutes of HFNC or NC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start13 Dec 2019
- Primary completion31 Mar 2020
- Study completion9 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Small Airway DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fu Jen Catholic University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yen-Liang Kuo, MD, Principal investigator, Fu Jen Catholic University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05130112
- Sponsor's protocol ID
- C107177
- Status last verified
- Oct 2021
- First submitted
- 7 Oct 2021
- Last updated
- 22 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05130112
- Acronym / sponsor ID
- C107177
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Fu Jen Catholic University HospitalUniversity, hospital or other
- Study start
- 13 Dec 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 9 Sep 2020 (actual)
- First posted
- 22 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HFNC then NC | Experimental | Device: high flow nasal cannula and nasal cannulaHigh flow nasal cannula for 10 min (Period 1) and nasal cannula for 10 min (Period 2) after a 4-week washout period |
| NC then HFNC | Experimental | Device: high flow nasal cannula and nasal cannulaNasal cannula for 10 min (Period 1) and high flow nasal cannula for 10 min (Period 2) after a 4-week washout period |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high flow nasal cannula and nasal cannulaHFNC 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. | Device | HFNC then NC, NC then HFNC |
Primary outcome
R5
Time frame: immediately after 10 minutes of HFNC or NC
Changes of R5
R5%
Time frame: immediately after 10 minutes of HFNC or NC
Changes of R5%
R20
Time frame: immediately after 10 minutes of HFNC or NC
Changes of R20
R20%
Time frame: immediately after 10 minutes of HFNC or NC
Changes of R20%
Changes of R5-20
Time frame: immediately after 10 minutes of HFNC or NC
R5-20
X5-predicted
Time frame: immediately after 10 minutes of HFNC or NC
Changes of X5-predicted
X5-predicted%
Time frame: immediately after 10 minutes of HFNC or NC
Changes of X5-predicted%
Changes of Fres
Time frame: immediately after 10 minutes of HFNC or NC
Fres
Changes of Fres%
Time frame: immediately after 10 minutes of HFNC or NC
Fres%
Changes of Ax
Time frame: immediately after 10 minutes of HFNC or NC
Ax
Ax%
Time frame: immediately after 10 minutes of HFNC or NC
Changes of Ax%
18 secondary outcomes
TcPCO2
Time frame: immediately after 10 minutes of HFNC or NC
Body temperature
Time frame: immediately after 10 minutes of HFNC or NC
pulse rate
Time frame: immediately after 10 minutes of HFNC or NC
respiratory rate
Time frame: immediately after 10 minutes of HFNC or NC
both systolic and diastolic blood pressure
Time frame: immediately after 10 minutes of HFNC or NC
SpO2
Time frame: immediately after 10 minutes of HFNC or NC
FEV1
Time frame: immediately after 10 minutes of HFNC or NC
FEV1%
Time frame: immediately after 10 minutes of HFNC or NC
FVC
Time frame: immediately after 10 minutes of HFNC or NC
FVC%
Time frame: immediately after 10 minutes of HFNC or NC
FEV1/FVC%
Time frame: immediately after 10 minutes of HFNC or NC
Changes of FEV3
Time frame: immediately after 10 minutes of HFNC or NC
FEV3%
Time frame: immediately after 10 minutes of HFNC or NC
FEV3/FVC%
Time frame: immediately after 10 minutes of HFNC or NC
MMEF
Time frame: immediately after 10 minutes of HFNC or NC
Changes of MMEF%
Time frame: immediately after 10 minutes of HFNC or NC
PEF
Time frame: immediately after 10 minutes of HFNC or NC
PEF%
Time frame: immediately after 10 minutes of HFNC or NC
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2021.
- Derived from this study: PubMed 35484186Kuo 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yen-Liang Kuo, MD principal investigator
Fu Jen Catholic University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high flow nasal cannula and nasal cannula in people with Small Airway Disorders and COPD, run by Fu Jen Catholic University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
R5 (time frame: immediately after 10 minutes of HFNC or NC). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05130112, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2021; AzTrials last refreshed its copy on 1 Nov 2026.