Clinical trial NCT05130112: Impact of Airways Function After HFNC Evaluated by IOS
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Fu Jen Catholic University Hospital
Sponsor class: OTHER
First posted: 2021-11-22
Enrollment: 26
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: R5
timeFrame: immediately after 10 minutes of HFNC or NC
measure: R5%
timeFrame: immediately after 10 minutes of HFNC or NC
measure: R20
timeFrame: immediately after 10 minutes of HFNC or NC
measure: R20%
timeFrame: immediately after 10 minutes of HFNC or NC
measure: Changes of R5-20
timeFrame: immediately after 10 minutes of HFNC or NC
measure: X5-predicted
timeFrame: immediately after 10 minutes of HFNC or NC
measure: X5-predicted%
timeFrame: immediately after 10 minutes of HFNC or NC
measure: Changes of Fres
timeFrame: immediately after 10 minutes of HFNC or NC
measure: Changes of Fres%
timeFrame: immediately after 10 minutes of HFNC or NC
measure: Changes of Ax
timeFrame: immediately after 10 minutes of HFNC or NC
measure: Ax%
timeFrame: immediately after 10 minutes of HFNC or NC
Secondary outcomes:
measure: TcPCO2
timeFrame: immediately after 10 minutes of HFNC or NC
measure: Body temperature
timeFrame: immediately after 10 minutes of HFNC or NC
measure: pulse rate
timeFrame: immediately after 10 minutes of HFNC or NC
measure: respiratory rate
timeFrame: immediately after 10 minutes of HFNC or NC
measure: both systolic and diastolic blood pressure
timeFrame: immediately after 10 minutes of HFNC or NC
measure: SpO2
timeFrame: immediately after 10 minutes of HFNC or NC
measure: FEV1
timeFrame: immediately after 10 minutes of HFNC or NC
measure: FEV1%
timeFrame: immediately after 10 minutes of HFNC or NC
measure: FVC
timeFrame: immediately after 10 minutes of HFNC or NC
measure: FVC%
timeFrame: immediately after 10 minutes of HFNC or NC
measure: FEV1/FVC%
timeFrame: immediately after 10 minutes of HFNC or NC
measure: Changes of FEV3
timeFrame: immediately after 10 minutes of HFNC or NC
measure: FEV3%
timeFrame: immediately after 10 minutes of HFNC or NC
measure: FEV3/FVC%
timeFrame: immediately after 10 minutes of HFNC or NC
measure: MMEF
timeFrame: immediately after 10 minutes of HFNC or NC
measure: Changes of MMEF%
timeFrame: immediately after 10 minutes of HFNC or NC
measure: PEF
timeFrame: immediately after 10 minutes of HFNC or NC
measure: PEF%
timeFrame: immediately after 10 minutes of HFNC or NC
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Yen-Liang Kuo
Study officials:
affiliation: Fu Jen Catholic University Hospital
name: Yen-Liang Kuo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.