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Helmet Ventilation During Self-Paced Walking Test

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04156724
Enrollment
20
Registered
2019-11-07
Start date
2020-07-14
Completion date
2021-02-01
Last updated
2021-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD

Brief summary

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

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.

Interventions

DEVICEHelmet vetilation

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

Sponsors

Fu Jen Catholic University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
6WMD2 daysWalking distance of six minute walking test

Secondary

MeasureTime frameDescription
Heart rate2 daysHeart rate of six minute walking test
Respiratory rate2 daysRespiratory rate of six minute walking test
modified Borg dyspnea scale2 daysA self report level of dyspnea score ranging from 0 to 10, 0 represent no dyspnea and 10 represents the worse

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026