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The Clinical Application and Popularization of Portable Home Noninvasive Ventilator

The Clinical Application and Popularization of Portable Home Noninvasive Ventilator

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03238339
Enrollment
40
Registered
2017-08-03
Start date
2017-09-15
Completion date
2020-12-30
Last updated
2019-12-23

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

Conditions

Hypercapnic Respiratory Failure, Pulmonary Disease, Chronic Obstructive

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

Mingdong Hu
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No

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

MeasureTime frameDescription
The frequency of the chronic obstructive pulmonary disease(COPD) acute exacerbation.one yearRecord the frequency of COPD acute exacerbation within one year

Secondary

MeasureTime frameDescription
The first onset time of the chronic obstructive pulmonary disease(COPD) acute exacerbationone yearRecord the first onset time of COPD acute exacerbation
The number of hospitalizations due to the chronic obstructive pulmonary disease(COPD) acute exacerbationone yearRecord the number of hospitalizations due to the COPD acute exacerbation

Other

MeasureTime frameDescription
routine analysis of bloodmonth0,month4,month8,month12
Six Minute Walk Distancemonth0,month4,month8,month12
The change of cytokines expressionmonth0,month4,month8,month12The cytokines including IL8、IL13、TNF-a、INF-r、IFN-γ、LTB4.
pulmonary arterial pressuremonth0,month4,month8,month12
arterial blood gasmonth0,month4,month8,month12

Countries

China

Contacts

Primary ContactHu Mingdong, MD
huhanshandd@163.com+86-13500362524

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026