Helmet Ventilation During Self-Paced Walking Test

September 24, 2021 updated by: Ke-Yun, Chao, Fu Jen Catholic University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • New Taipei City, Taiwan, 24352
        • Fu Jen Catholic University Hospital, Fu Jen Catholic University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HV
6MWT with helmet ventilation
Device: Helmet vetilation
We will apply non-invasive positive pressure ventilation via a helmet as interface
No Intervention: Control
6MWT alone according to ATS guideline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6WMD
Time Frame: 2 days
Walking distance of six minute walking test
2 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate
Time Frame: 2 days
Heart rate of six minute walking test
2 days
Respiratory rate
Time Frame: 2 days
Respiratory rate of six minute walking test
2 days
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
2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fu Jen Catholic University

Investigators

  • Principal Investigator: Wen-Lun Liu, MD, Department of Emergency and Critical Care Medicine, Fu Jen Catholic University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 14, 2020

Primary Completion (Actual)

February 1, 2021

Study Completion (Actual)

February 1, 2021

Study Registration Dates

First Submitted

November 6, 2019

First Submitted That Met QC Criteria

November 6, 2019

First Posted (Actual)

November 7, 2019

Study Record Updates

Last Update Posted (Actual)

September 30, 2021

Last Update Submitted That Met QC Criteria

September 24, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • C108032

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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