Impact of Airways Function After HFNC Evaluated by IOS
- Conditions
- Small Airway DisordersCOPD
- Interventions
- Device: high flow nasal cannula and nasal cannula
- Registration Number
- NCT05130112
- Lead Sponsor
- Fu Jen Catholic University Hospital
- Brief 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.
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description HFNC then NC high flow nasal cannula and nasal cannula High 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 high flow nasal cannula and nasal cannula Nasal cannula for 10 min (Period 1) and high flow nasal cannula for 10 min (Period 2) after a 4-week washout period
- Primary Outcome Measures
Name Time Method R5 immediately after 10 minutes of HFNC or NC Changes of R5
R5% immediately after 10 minutes of HFNC or NC Changes of R5%
R20% immediately after 10 minutes of HFNC or NC Changes of R20%
R20 immediately after 10 minutes of HFNC or NC Changes of R20
X5-predicted immediately after 10 minutes of HFNC or NC Changes of X5-predicted
Changes of R5-20 immediately after 10 minutes of HFNC or NC R5-20
X5-predicted% immediately after 10 minutes of HFNC or NC Changes of X5-predicted%
Changes of Fres immediately after 10 minutes of HFNC or NC Fres
Changes of Fres% immediately after 10 minutes of HFNC or NC Fres%
Ax% immediately after 10 minutes of HFNC or NC Changes of Ax%
Changes of Ax immediately after 10 minutes of HFNC or NC Ax
- Secondary Outcome Measures
Name Time Method respiratory rate immediately after 10 minutes of HFNC or NC Changes of respiratory rate
both systolic and diastolic blood pressure immediately after 10 minutes of HFNC or NC Changes of both systolic and diastolic blood pressure
PEF immediately after 10 minutes of HFNC or NC Changes of PEF
FEV1% immediately after 10 minutes of HFNC or NC Changes of FEV1%
FVC immediately after 10 minutes of HFNC or NC Changes of FVC
PEF% immediately after 10 minutes of HFNC or NC Changes of PEF%
FEV1/FVC% immediately after 10 minutes of HFNC or NC Changes of FEV1/FVC%
Changes of MMEF% immediately after 10 minutes of HFNC or NC MMEF%
Body temperature immediately after 10 minutes of HFNC or NC Changes of body temperature
Changes of FEV3 immediately after 10 minutes of HFNC or NC FEV3
MMEF immediately after 10 minutes of HFNC or NC Changes of MMEF
TcPCO2 immediately after 10 minutes of HFNC or NC Changes of TcPCO2
pulse rate immediately after 10 minutes of HFNC or NC Changes of pulse rate
SpO2 immediately after 10 minutes of HFNC or NC Changes of SpO2
FEV1 immediately after 10 minutes of HFNC or NC Changes of FEV1
FVC% immediately after 10 minutes of HFNC or NC Changes of FVC%
FEV3% immediately after 10 minutes of HFNC or NC Changes of FEV3%
FEV3/FVC% immediately after 10 minutes of HFNC or NC Changes of FEV3/FVC%
Trial Locations
- Locations (1)
Yen-Liang Kuo
🇨🇳New Taipei City, Taiwan