Impact of Airways Function After HFNC Evaluated by IOS

NCT05130112 | Completed FDA Device

• 1 other identifier: C107177
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (18)

• TcPCO2

  immediately after 10 minutes of HFNC or NC

• Body temperature

  immediately after 10 minutes of HFNC or NC

• pulse rate

  immediately after 10 minutes of HFNC or NC

• respiratory rate

  immediately after 10 minutes of HFNC or NC

• both systolic and diastolic blood pressure

  immediately after 10 minutes of HFNC or NC

Study Arms (2)

HFNC then NC

EXPERIMENTAL

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

NC then HFNC

EXPERIMENTAL

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

Interventions

high flow nasal cannula and nasal cannula 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.

HFNC then NC; NC then HFNC

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fu Jen Catholic University Hospital: lead

Study Sites (1)

Yen-Liang Kuo

New Taipei City, 24205, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 35484186 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Cannula

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Catheters; Equipment and Supplies

Study Officials

• Yen-Liang Kuo, MD

  Fu Jen Catholic University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: November 22, 2021
• Study Start: December 13, 2019
• Primary Completion: March 31, 2020
• Study Completion: September 9, 2020
• Last Updated: November 22, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)