The Application and Analysis of HHHFNC in Walking Test of Pulmonary Rehabilitation

Not Applicable

Completed

• Conditions: Rehabilitation; COPD; Pulmonary Disease
• Interventions: Device: HHHFNC

• Registration Number: NCT03863821
• Lead Sponsor: Fu Jen Catholic University

Brief Summary

The aim of this study is to investigate the use heated humidified high-flow nasal cannula (HHHFNC) in pulmonary rehabilitation and analysis of cardiopulmonary parameters in adult patients.

Detailed Description

Objectives： The aim of this study is to investigate the use heated humidified high-flow nasal cannula (HHHFNC) in pulmonary rehabilitation and analysis of cardiopulmonary parameters in adult patients.

Background： Recently, HHHFNC has been used in both adult and neonates with post-extubation respiratory support. Studies indicate that HHHFNC has similar efficacy compared to non-invasive positive pressure ventilation and superior than conventional oxygen therapy. Six-minute walking test (6-MWT) is a standardized laboratory tests to evaluate the endurance capacity in adult patients. It helps clinician to modify the treatment plan. Cirio, et at. has been shown HHHFNC may improve the exercise performance in severe chronic obstructive pulmonary disease (COPD) patients with ventilatory limitation.

Study Design： This is a prospective clinical trial in a pulmonary rehabilitation out-patient department (2018.08.01-2019.07.31).。 Methods： Patents with COPD who done pulmonary function test will enroll to this study. Left-side heart failure, COPD acute-exacerbation (AE) within 3 months, diagnosed neuromuscular disease, and unable to perform 6-MWT will be exclude. The data will be collected for and analyzed.

Effect： Investigators expect the exercise performance; cardiopulmonary function will be improve under HHHFNC support. We hope the application of HHHFNC in adult patient with pulmonary rehabilitation could enhance the quality of life.

Key words： chronic obstructive pulmonary disease; heated humidified high-flow nasal cannula; pulmonary rehabilitation, six-minute walking test.

Study Timeline

• Study First Submitted: 2019-03-04
• Study First Submitted QC: 2019-03-04
• Study First Posted: 2019-03-05
• Study Start: 2019-03-18
• Status Verified: 2019-11
• Primary Completion: 2019-11-30
• Study Completion: 2019-11-30
• Last Update Submitted: 2019-12-26
• Last Update Posted: 2019-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• COPD with performed pulmonary function test

Exclusion Criteria

• Left-side heart failure
• COPD exacerbation within 3 month
• Diagnosed neuromuscular disease
• Unable to perform 6-MWT

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
HHHFNC group	HHHFNC	Practice 6 MWT with HHHFNC

Primary Outcome Measures

Name	Time	Method
Walking distance	6 minutes	Meter

Secondary Outcome Measures

Name	Time	Method
Transcutaneous carbon dioxide (PtcCO2)	1 hour	mmHg
Cardiac output by non-invasive cardiometry	1 hour	mL
Borg dyspnea scale	1 hour	0-10 level (level 10 means worst)
Heart rate	1 hour	beat per minute
Oxygen saturation (SpO2)	1 hour

Trial Locations

Locations (1)

Fu Jen Catholic University Hospital, Fu Jen Catholic University; 🇨🇳 New Taipei City, Taiwan