Hypercapnic Respiratory Failure, Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
Pulmonary Disease, Chronic Obstructive, Respiratory Insufficiency, Oxygen Inhalation Therapy, Noninvasive Ventilation
Brief summary
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.
Interventions
None listed
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The frequency of the chronic obstructive pulmonary disease(COPD) acute exacerbation. | one year | Record the frequency of COPD acute exacerbation within one year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The first onset time of the chronic obstructive pulmonary disease(COPD) acute exacerbation | one year | Record the first onset time of COPD acute exacerbation |
| The number of hospitalizations due to the chronic obstructive pulmonary disease(COPD) acute exacerbation | one year | Record the number of hospitalizations due to the COPD acute exacerbation |
Other
| Measure | Time frame | Description |
|---|---|---|
| routine analysis of blood | month0,month4,month8,month12 | — |
| Six Minute Walk Distance | month0,month4,month8,month12 | — |
| The change of cytokines expression | month0,month4,month8,month12 | The cytokines including IL8、IL13、TNF-a、INF-r、IFN-γ、LTB4. |
| pulmonary arterial pressure | month0,month4,month8,month12 | — |
| arterial blood gas | month0,month4,month8,month12 | — |
Countries
China