Clinical trial NCT03863821: 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
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Pulmonary Disease
Rehabilitation
Keywords: chronic obstructive pulmonary disease
heated humidified high-flow nasal cannula
pulmonary rehabilitation
six-minute walking test
Lead sponsor: Fu Jen Catholic University
Sponsor class: OTHER
First posted: 2019-03-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Walking distance
timeFrame: 6 minutes
Secondary outcomes:
measure: Heart rate
timeFrame: 1 hour
measure: Oxygen saturation (SpO2)
timeFrame: 1 hour
measure: Transcutaneous carbon dioxide (PtcCO2)
timeFrame: 1 hour
measure: Cardiac output by non-invasive cardiometry
timeFrame: 1 hour
measure: Borg dyspnea scale
timeFrame: 1 hour
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Fu Jen Catholic University Hospital, Fu Jen Catholic University
Study officials:
References:
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.
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.
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.
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.