The Application and Analysis of HHHFNC in Walking Test of Pulmonary Rehabilitation
NCT ID: NCT03863821
Last Updated: 2019-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
30 participants
INTERVENTIONAL
2019-03-18
2019-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
Participants will received HHHNFC or non-HHHFNC support during the 6-MWT.
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
HHHFNC group
Practice 6 MWT with HHHFNC
HHHFNC
HHHFNC setting:
1. Flow rate: 40L/min
2. FiO2: 0.4
HHHFNC will use immediately before 6MWT and remove at the end of 6MWT
non-HHHFNC group
Practice 6 MWT without HHHFNC
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
HHHFNC
HHHFNC setting:
1. Flow rate: 40L/min
2. FiO2: 0.4
HHHFNC will use immediately before 6MWT and remove at the end of 6MWT
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* COPD exacerbation within 3 month
* Diagnosed neuromuscular disease
* Unable to perform 6-MWT
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fu Jen Catholic University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ke-Yun, Chao
Group leader of Respiratory Therapists
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Fu Jen Catholic University Hospital, Fu Jen Catholic University
New Taipei City, , Taiwan
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PL-201808008-M
Identifier Type: -
Identifier Source: org_study_id