Impact of Airways Function After HFNC Evaluated by IOS

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Small Airway Disorders, COPD

Intervention / Treatment
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* Device: high flow nasal cannula and nasal cannula


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HFNC then NC<br>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<br>* 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.<br>|
| Experimental: NC then HFNC<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| R5 | Changes of R5 | immediately after 10 minutes of HFNC or NC | 
| R5% | Changes of R5% | immediately after 10 minutes of HFNC or NC | 
| R20 | Changes of R20 | immediately after 10 minutes of HFNC or NC | 
| R20% | Changes of R20% | immediately after 10 minutes of HFNC or NC | 
| Changes of R5-20 | R5-20 | immediately after 10 minutes of HFNC or NC | 
| X5-predicted | Changes of X5-predicted | immediately after 10 minutes of HFNC or NC | 
| X5-predicted% | Changes of X5-predicted% | immediately after 10 minutes of HFNC or NC | 
| Changes of Fres | Fres | immediately after 10 minutes of HFNC or NC | 
| Changes of Fres% | Fres% | immediately after 10 minutes of HFNC or NC | 
| Changes of Ax | Ax | immediately after 10 minutes of HFNC or NC | 
| Ax% | Changes of Ax% | immediately after 10 minutes of HFNC or NC | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TcPCO2 | Changes of TcPCO2 | immediately after 10 minutes of HFNC or NC | 
| Body temperature | Changes of body temperature | immediately after 10 minutes of HFNC or NC | 
| pulse rate | Changes of pulse rate | immediately after 10 minutes of HFNC or NC | 
| respiratory rate | Changes of respiratory rate | immediately after 10 minutes of HFNC or NC | 
| both systolic and diastolic blood pressure | Changes of both systolic and diastolic blood pressure | immediately after 10 minutes of HFNC or NC | 
| SpO2 | Changes of SpO2 | immediately after 10 minutes of HFNC or NC | 
| FEV1 | Changes of FEV1 | immediately after 10 minutes of HFNC or NC | 
| FEV1% | Changes of FEV1% | immediately after 10 minutes of HFNC or NC | 
| FVC | Changes of FVC | immediately after 10 minutes of HFNC or NC | 
| FVC% | Changes of FVC% | immediately after 10 minutes of HFNC or NC | 
| FEV1/FVC% | Changes of FEV1/FVC% | immediately after 10 minutes of HFNC or NC | 
| Changes of FEV3 | FEV3 | immediately after 10 minutes of HFNC or NC | 
| FEV3% | Changes of FEV3% | immediately after 10 minutes of HFNC or NC | 
| FEV3/FVC% | Changes of FEV3/FVC% | immediately after 10 minutes of HFNC or NC | 
| MMEF | Changes of MMEF | immediately after 10 minutes of HFNC or NC | 
| Changes of MMEF% | MMEF% | immediately after 10 minutes of HFNC or NC | 
| PEF | Changes of PEF | immediately after 10 minutes of HFNC or NC | 
| PEF% | Changes of PEF% | immediately after 10 minutes of HFNC or NC | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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high-flow nasal cannula, high nasal flow, chronic obstructive pulmonary disease (COPD), airway impedance, distal airway, peripheral airway, airway resistance