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

NCT ID: NCT03863821

Last Updated: 2019-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-18

Study Completion Date

2019-11-30

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.

Conditions

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COPD Pulmonary Disease Rehabilitation

Keywords

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chronic obstructive pulmonary disease heated humidified high-flow nasal cannula pulmonary rehabilitation six-minute walking test

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HHHFNC group

Practice 6 MWT with HHHFNC

Group Type EXPERIMENTAL

HHHFNC

Intervention Type DEVICE

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fu Jen Catholic University

OTHER

Sponsor Role lead

Responsible Party

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Ke-Yun, Chao

Group leader of Respiratory Therapists

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fu Jen Catholic University Hospital, Fu Jen Catholic University

New Taipei City, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type RESULT
PMID: 27578482 (View on PubMed)

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.

Reference Type RESULT
PMID: 25452426 (View on PubMed)

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.

Reference Type RESULT
PMID: 15170026 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34941043 (View on PubMed)

Other Identifiers

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PL-201808008-M

Identifier Type: -

Identifier Source: org_study_id