Impact of Airways Function After HFNC Evaluated by IOS

NCT ID: NCT05130112

Last Updated: 2021-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-13
• Study Completion Date: 2020-09-09

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).

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

high flow nasal cannula and nasal cannula

Intervention Type: DEVICE

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.

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

Group Type: EXPERIMENTAL

high flow nasal cannula and nasal cannula

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fu Jen Catholic University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yen-Liang Kuo, MD

Role: PRINCIPAL_INVESTIGATOR

Fu Jen Catholic University Hospital

Locations

Yen-Liang Kuo

New Taipei City, , Taiwan

Countries

Taiwan

References

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.

Reference Type: DERIVED

PMID: 35484186 (View on PubMed)

Other Identifiers

C107177

Identifier Type: -

Identifier Source: org_study_id