Impact of Airways Function After HFNC Evaluated by IOS

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.

Study Overview

• Status: Completed
• Conditions: COPD; Small Airway Disorders
• Intervention / Treatment: Device: high flow nasal cannula and nasal cannula

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 Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • New Taipei City, Taiwan, 24205
    • Yen-Liang Kuo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: HFNC then NC; 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; 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.
EXPERIMENTAL: NC then HFNC; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fu Jen Catholic University Hospital
• Investigators: Principal Investigator: Yen-Liang Kuo, MD, Fu Jen Catholic University Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 13, 2019
• Primary Completion (ACTUAL): March 31, 2020
• Study Completion (ACTUAL): September 9, 2020

Study Registration Dates

• First Submitted: October 7, 2021
• First Submitted That Met QC Criteria: November 17, 2021
• First Posted (ACTUAL): November 22, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 22, 2021
• Last Update Submitted That Met QC Criteria: November 17, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: airway resistance; high-flow nasal cannula; chronic obstructive pulmonary disease (COPD); high nasal flow; airway impedance; distal airway; peripheral airway
• Other Study ID Numbers: C107177

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes