The Clinical Application and Popularization of Portable Home Noninvasive Ventilator

Study Overview
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Brief Summary
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The subjects of this study are the chronic obstructive pulmonary disease (COPD) patients with chronic II respiratory failure. The participants will be divided into two groups: The Portable Home Noninvasive Ventilator treatment group and the routine home oxygen inhalation treatment group. All subjects will be given a stable COPD regimen and conventional oxygen therapy ,but the portable home noninvasive ventilator treatment group will need to wear a portable non-invasive ventilator. Objective evaluation indexes were established during the routine treatment, and two groups of subjects will be followed up for one year. Finally, the clinical data of all subjects will be analyzed，and then the practicability of portable wearable household noninvasive ventilator will be verified.The researchers will also build a remote breathing data-monitoring platform based on mobile internet,and a community home demonstration application point.

Official Title
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The Clinical Application and Popularization of Portable Home Noninvasive Ventilator

Conditions
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Pulmonary Disease, Chronic Obstructive, Hypercapnic Respiratory Failure

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 40 years old < age < 80 years old COPD diagnosis was made according to GOLD guidelines The subjects with chronic type II respiratory failure The subjects with structural lung disease The subjects signed informed consent. Exclusion Criteria: The subjects suffering from COPD acute exacerbation The subjects currently participating in other related products The subjects with organ dysfunction because of liver,kidney, hematopoietic system and serious metabolic disease endocrine system The subjects with poor compliance The subjects refused to sign the informed consent

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| The Portable Home Noninvasive Ventilator treatment group<br>The patients maintain a stable COPD regimen, and on the basis of conventional home oxygen therapy, a portable, wearable, non-invasive ventilator will be used. | |
| Routine home oxygen therapy group<br>The patient maintained a stable COPD regimen and conventional home oxygen therapy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The frequency of the chronic obstructive pulmonary disease(COPD) acute exacerbation. | Record the frequency of COPD acute exacerbation within one year | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The first onset time of the chronic obstructive pulmonary disease(COPD) acute exacerbation | Record the first onset time of COPD acute exacerbation | one year | 
| The number of hospitalizations due to the chronic obstructive pulmonary disease(COPD) acute exacerbation | Record the number of hospitalizations due to the COPD acute exacerbation | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulmonary Disease, Chronic Obstructive, Respiratory Insufficiency, Oxygen Inhalation Therapy, Noninvasive Ventilation