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Completed

NCT Number: NCT03863821

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fu Jen Catholic University Hospital, Fu Jen Catholic University

New Taipei City, 24352, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HHHFNC

Device

HHHFNC setting:

  • Flow rate: 40L/min
  • FiO2: 0.4

HHHFNC will use immediately before 6MWT and remove at the end of 6MWT

Primary outcomes

  1. Walking distance

    Time frame: 6 minutes

    Meter

Secondary outcomes

  1. Heart rate

    Time frame: 1 hour

    beat per minute

  2. Oxygen saturation (SpO2)

    Time frame: 1 hour

  3. Transcutaneous carbon dioxide (PtcCO2)

    Time frame: 1 hour

    mmHg

  4. Cardiac output by non-invasive cardiometry

    Time frame: 1 hour

    mL

  5. Borg dyspnea scale

    Time frame: 1 hour

    0-10 level (level 10 means worst)

Sponsors and collaborators

Lead sponsor

Fu Jen Catholic University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 5, 2019
Registry last updated
Dec 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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