Clinical trial NCT03238339: The Clinical Application and Popularization of Portable Home Noninvasive Ventilator
Official title: The Clinical Application and Popularization of Portable Home Noninvasive Ventilator
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Disease, Chronic Obstructive
Hypercapnic Respiratory Failure
Keywords: Pulmonary Disease, Chronic Obstructive
Respiratory Insufficiency
Oxygen Inhalation Therapy
Noninvasive Ventilation
Lead sponsor: Third Military Medical University
Sponsor class: OTHER
First posted: 2017-08-03
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The subjects were selected from the Department of respiration, Xinqiao Hospital of Chongqing city.

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.


Eligibility criteria: 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

Primary outcomes:
measure: The frequency of the chronic obstructive pulmonary disease(COPD) acute exacerbation.
timeFrame: one year
Secondary outcomes:
measure: The first onset time of the chronic obstructive pulmonary disease(COPD) acute exacerbation
timeFrame: one year
measure: The number of hospitalizations due to the chronic obstructive pulmonary disease(COPD) acute exacerbation
timeFrame: one year
Other outcomes:
measure: Six Minute Walk Distance
timeFrame: month0,month4,month8,month12
measure: pulmonary arterial pressure
timeFrame: month0,month4,month8,month12
measure: arterial blood gas
timeFrame: month0,month4,month8,month12
measure: routine analysis of blood
timeFrame: month0,month4,month8,month12
measure: The change of cytokines expression
timeFrame: month0,month4,month8,month12
Locations:
city: Chongqing
country: China
facility: Emergency Department, Xinqiao Hospital, Third Military Medical University
Study officials:
References: