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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Heated Humidified High-Flow Nasal Cannula During Six-Minute Walk Test in Patient With COPD Undergoing Pulmonary Rehabilitation

Conditions
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COPD, Pulmonary Disease, Rehabilitation

Intervention / Treatment
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* Device: HHHFNC


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Participants with COPD who done pulmonary function test will enroll to this study. Left-side heart failure, COPD AE within 3 months, diagnosed neuromuscular disease, and unable to perform 6-MWT will be exclude. Participants will received HHHNFC or non-HHHFNC support during the 6-MWT.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HHHFNC group<br>Practice 6 MWT with HHHFNC | Device: HHHFNC<br>* HHHFNC setting: Flow rate: 40L/min FiO2: 0.4 HHHFNC will use immediately before 6MWT and remove at the end of 6MWT<br>|
| No Intervention: non-HHHFNC group<br>Practice 6 MWT without HHHFNC | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Walking distance | Meter | 6 minutes | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic obstructive pulmonary disease, heated humidified high-flow nasal cannula, pulmonary rehabilitation, six-minute walking test