Impact of Airways Function After HFNC Evaluated by IOS

COPD Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05130112
• Other study ID #: C107177
• Status: Completed
• Phase: N/A
• Start date: December 13, 2019
• Est. completion date: September 9, 2020

Study information

• Verified date: October 2021
• Source: Fu Jen Catholic University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: September 9, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• COPD

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Yen-Liang Kuo	New Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Fu Jen Catholic University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	R5	Changes of R5	immediately after 10 minutes of HFNC or NC
Primary	R5%	Changes of R5%	immediately after 10 minutes of HFNC or NC
Primary	R20	Changes of R20	immediately after 10 minutes of HFNC or NC
Primary	R20%	Changes of R20%	immediately after 10 minutes of HFNC or NC
Primary	Changes of R5-20	R5-20	immediately after 10 minutes of HFNC or NC
Primary	X5-predicted	Changes of X5-predicted	immediately after 10 minutes of HFNC or NC
Primary	X5-predicted%	Changes of X5-predicted%	immediately after 10 minutes of HFNC or NC
Primary	Changes of Fres	Fres	immediately after 10 minutes of HFNC or NC
Primary	Changes of Fres%	Fres%	immediately after 10 minutes of HFNC or NC
Primary	Changes of Ax	Ax	immediately after 10 minutes of HFNC or NC
Primary	Ax%	Changes of Ax%	immediately after 10 minutes of HFNC or NC
Secondary	TcPCO2	Changes of TcPCO2	immediately after 10 minutes of HFNC or NC
Secondary	Body temperature	Changes of body temperature	immediately after 10 minutes of HFNC or NC
Secondary	pulse rate	Changes of pulse rate	immediately after 10 minutes of HFNC or NC
Secondary	respiratory rate	Changes of respiratory rate	immediately after 10 minutes of HFNC or NC
Secondary	both systolic and diastolic blood pressure	Changes of both systolic and diastolic blood pressure	immediately after 10 minutes of HFNC or NC
Secondary	SpO2	Changes of SpO2	immediately after 10 minutes of HFNC or NC
Secondary	FEV1	Changes of FEV1	immediately after 10 minutes of HFNC or NC
Secondary	FEV1%	Changes of FEV1%	immediately after 10 minutes of HFNC or NC
Secondary	FVC	Changes of FVC	immediately after 10 minutes of HFNC or NC
Secondary	FVC%	Changes of FVC%	immediately after 10 minutes of HFNC or NC
Secondary	FEV1/FVC%	Changes of FEV1/FVC%	immediately after 10 minutes of HFNC or NC
Secondary	Changes of FEV3	FEV3	immediately after 10 minutes of HFNC or NC
Secondary	FEV3%	Changes of FEV3%	immediately after 10 minutes of HFNC or NC
Secondary	FEV3/FVC%	Changes of FEV3/FVC%	immediately after 10 minutes of HFNC or NC
Secondary	MMEF	Changes of MMEF	immediately after 10 minutes of HFNC or NC
Secondary	Changes of MMEF%	MMEF%	immediately after 10 minutes of HFNC or NC
Secondary	PEF	Changes of PEF	immediately after 10 minutes of HFNC or NC
Secondary	PEF%	Changes of PEF%	immediately after 10 minutes of HFNC or NC