The Application and Analysis of HHHFNC in Walking Test of Pulmonary Rehabilitation
Primary Purpose
COPD, Pulmonary Disease, Rehabilitation
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
HHHFNC
Sponsored by
About this trial
This is an interventional treatment trial for COPD focused on measuring chronic obstructive pulmonary disease, heated humidified high-flow nasal cannula, pulmonary rehabilitation, six-minute walking test
Eligibility Criteria
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
Sites / Locations
- Fu Jen Catholic University Hospital, Fu Jen Catholic University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
HHHFNC group
non-HHHFNC group
Arm Description
Practice 6 MWT with HHHFNC
Practice 6 MWT without HHHFNC
Outcomes
Primary Outcome Measures
Walking distance
Meter
Secondary Outcome Measures
Heart rate
beat per minute
Oxygen saturation (SpO2)
Transcutaneous carbon dioxide (PtcCO2)
mmHg
Cardiac output by non-invasive cardiometry
mL
Borg dyspnea scale
0-10 level (level 10 means worst)
Full Information
NCT ID
NCT03863821
First Posted
March 4, 2019
Last Updated
December 26, 2019
Sponsor
Fu Jen Catholic University
1. Study Identification
Unique Protocol Identification Number
NCT03863821
Brief Title
The Application and Analysis of HHHFNC in Walking Test of Pulmonary Rehabilitation
Official Title
Effects of Heated Humidified High-Flow Nasal Cannula During Six-Minute Walk Test in Patient With COPD Undergoing Pulmonary Rehabilitation
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
March 18, 2019 (Actual)
Primary Completion Date
November 30, 2019 (Actual)
Study Completion Date
November 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fu Jen Catholic University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Pulmonary Disease, Rehabilitation
Keywords
chronic obstructive pulmonary disease, heated humidified high-flow nasal cannula, pulmonary rehabilitation, six-minute walking test
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HHHFNC group
Arm Type
Experimental
Arm Description
Practice 6 MWT with HHHFNC
Arm Title
non-HHHFNC group
Arm Type
No Intervention
Arm Description
Practice 6 MWT without HHHFNC
Intervention Type
Device
Intervention Name(s)
HHHFNC
Intervention Description
HHHFNC setting:
Flow rate: 40L/min
FiO2: 0.4
HHHFNC will use immediately before 6MWT and remove at the end of 6MWT
Primary Outcome Measure Information:
Title
Walking distance
Description
Meter
Time Frame
6 minutes
Secondary Outcome Measure Information:
Title
Heart rate
Description
beat per minute
Time Frame
1 hour
Title
Oxygen saturation (SpO2)
Time Frame
1 hour
Title
Transcutaneous carbon dioxide (PtcCO2)
Description
mmHg
Time Frame
1 hour
Title
Cardiac output by non-invasive cardiometry
Description
mL
Time Frame
1 hour
Title
Borg dyspnea scale
Description
0-10 level (level 10 means worst)
Time Frame
1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Fu Jen Catholic University Hospital, Fu Jen Catholic University
City
New Taipei City
ZIP/Postal Code
24352
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27578482
Citation
Cirio S, Piran M, Vitacca M, Piaggi G, Ceriana P, Prazzoli M, Paneroni M, Carlucci A. Effects of heated and humidified high flow gases during high-intensity constant-load exercise on severe COPD patients with ventilatory limitation. Respir Med. 2016 Sep;118:128-132. doi: 10.1016/j.rmed.2016.08.004. Epub 2016 Aug 8.
Results Reference
result
PubMed Identifier
25452426
Citation
Maltais F, Singh S, Donald AC, Crater G, Church A, Goh AH, Riley JH. Effects of a combination of umeclidinium/vilanterol on exercise endurance in patients with chronic obstructive pulmonary disease: two randomized, double-blind clinical trials. Ther Adv Respir Dis. 2014 Dec;8(6):169-81. doi: 10.1177/1753465814559209. Erratum In: Ther Adv Respir Dis. 2016 Jun;10(3):289.
Results Reference
result
PubMed Identifier
15170026
Citation
Man WD, Mustfa N, Nikoletou D, Kaul S, Hart N, Rafferty GF, Donaldson N, Polkey MI, Moxham J. Effect of salmeterol on respiratory muscle activity during exercise in poorly reversible COPD. Thorax. 2004 Jun;59(6):471-6. doi: 10.1136/thx.2003.019620.
Results Reference
result
PubMed Identifier
34941043
Citation
Chao KY, Liu WL, Nassef Y, Tseng CW, Wang JS. Effects of high-flow nasal cannula with oxygen on self-paced exercise performance in COPD: A randomized cross-over trial. Medicine (Baltimore). 2021 Dec 23;100(51):e28032. doi: 10.1097/MD.0000000000028032.
Results Reference
derived
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The Application and Analysis of HHHFNC in Walking Test of Pulmonary Rehabilitation
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