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Completed

NCT Number: NCT04156724

Helmet Ventilation During Self-Paced Walking Test

The aim of this study is to investigate the use helmet ventilation (HV) in walking test and analysis of effect patients with COPD.

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Key information

Conditions

COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

20 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

Chronic obstructive pulmonary disease (COPD) is characterized by persistent airflow limitation with chronic inflammation of the respiratory system. Symptoms of COPD may contribute to activity restriction, deconditioning and exercise intolerance. Non-invasive positive pressure ventilation (NIPPV) has been shown to improve exercise intolerance and health-related quality of life in patients with severe COPD. Helmet ventilation (HV) is a new option for NIPPV to alternative to nasal or face mask. A study which published on JAMA demonstrated the feasibility and benefits of HV. The aim of this study is to investigate the use helmet ventilation (HV) in walking test and analysis of effect patients with COPD.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patents with COPD who confirm by pulmonary function test

Exclusion criteria

  • COPD AE within 3 months
  • Diagnosed neuromuscular disease
  • Unable to perform 6-MWT

Treatment and study plan

Helmet vetilation

Device

We will apply non-invasive positive pressure ventilation via a helmet as interface

Primary outcomes

  1. 6WMD

    Time frame: 2 days

    Walking distance of six minute walking test

Secondary outcomes

  1. Heart rate

    Time frame: 2 days

    Heart rate of six minute walking test

  2. Respiratory rate

    Time frame: 2 days

    Respiratory rate of six minute walking test

  3. modified Borg dyspnea scale

    Time frame: 2 days

    A self report level of dyspnea score ranging from 0 to 10, 0 represent no dyspnea and 10 represents the worse

Sponsors and collaborators

Lead sponsor

Fu Jen Catholic University

Other

Registry information

Official study title

Helmet Ventilation During Self-Paced Walking Test With Chronic Obstructive Pulmonary Disease

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 7, 2019
Registry last updated
Sep 30, 2021

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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