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Clinical Trials/NCT05130112
NCT05130112CompletedNot Applicable

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

Fu Jen Catholic University Hospital2 sites in 1 country26 target enrollmentStarted: December 13, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
26
Locations
2
Primary Endpoint
R20

Study Overview

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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
20 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

R20

Time Frame: immediately after 10 minutes of HFNC or NC

Changes of R20

X5-predicted

Time Frame: immediately after 10 minutes of HFNC or NC

Changes of X5-predicted

R5

Time Frame: immediately after 10 minutes of HFNC or NC

Changes of R5

R5%

Time Frame: immediately after 10 minutes of HFNC or NC

Changes of R5%

R20%

Time Frame: immediately after 10 minutes of HFNC or NC

Changes of R20%

Changes of R5-20

Time Frame: immediately after 10 minutes of HFNC or NC

R5-20

X5-predicted%

Time Frame: immediately after 10 minutes of HFNC or NC

Changes of X5-predicted%

Changes of Fres

Time Frame: immediately after 10 minutes of HFNC or NC

Fres

Changes of Fres%

Time Frame: immediately after 10 minutes of HFNC or NC

Fres%

Ax%

Time Frame: immediately after 10 minutes of HFNC or NC

Changes of Ax%

Changes of Ax

Time Frame: immediately after 10 minutes of HFNC or NC

Ax

Secondary Outcomes

  • respiratory rate(immediately after 10 minutes of HFNC or NC)
  • both systolic and diastolic blood pressure(immediately after 10 minutes of HFNC or NC)
  • PEF(immediately after 10 minutes of HFNC or NC)
  • FEV1%(immediately after 10 minutes of HFNC or NC)
  • FVC(immediately after 10 minutes of HFNC or NC)
  • PEF%(immediately after 10 minutes of HFNC or NC)
  • FEV1/FVC%(immediately after 10 minutes of HFNC or NC)
  • Changes of MMEF%(immediately after 10 minutes of HFNC or NC)
  • Body temperature(immediately after 10 minutes of HFNC or NC)
  • Changes of FEV3(immediately after 10 minutes of HFNC or NC)
  • MMEF(immediately after 10 minutes of HFNC or NC)
  • TcPCO2(immediately after 10 minutes of HFNC or NC)
  • pulse rate(immediately after 10 minutes of HFNC or NC)
  • SpO2(immediately after 10 minutes of HFNC or NC)
  • FEV1(immediately after 10 minutes of HFNC or NC)
  • FVC%(immediately after 10 minutes of HFNC or NC)
  • FEV3%(immediately after 10 minutes of HFNC or NC)
  • FEV3/FVC%(immediately after 10 minutes of HFNC or NC)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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