Skip to main content
Clinical Trials/NCT03238339
NCT03238339
Unknown
Not Applicable

The Clinical Application and Popularization of Portable Home Noninvasive Ventilator

Mingdong Hu1 site in 1 country40 target enrollmentSeptember 15, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pulmonary Disease, Chronic Obstructive
Sponsor
Mingdong Hu
Enrollment
40
Locations
1
Primary Endpoint
The frequency of the chronic obstructive pulmonary disease(COPD) acute exacerbation.
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 15, 2017
End Date
December 30, 2020
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Mingdong Hu
Responsible Party
Sponsor Investigator
Principal Investigator

Mingdong Hu

associate chief physician

Third Military Medical University

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

Outcomes

Primary Outcomes

The frequency of the chronic obstructive pulmonary disease(COPD) acute exacerbation.

Time Frame: one year

Record the frequency of COPD acute exacerbation within one year

Secondary Outcomes

  • The first onset time of the chronic obstructive pulmonary disease(COPD) acute exacerbation(one year)
  • The number of hospitalizations due to the chronic obstructive pulmonary disease(COPD) acute exacerbation(one year)

Study Sites (1)

Loading locations...

Similar Trials