The Clinical Application and Popularization of Portable Home Noninvasive Ventilator

• Conditions: Pulmonary Disease, Chronic Obstructive; Hypercapnic Respiratory Failure

• Registration Number: NCT03238339
• Lead Sponsor: Mingdong Hu

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-31
• Study First Submitted QC: 2017-07-31
• Study First Posted: 2017-08-03
• Study Start: 2017-09-15
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-20
• Last Update Posted: 2019-12-23
• Primary Completion: 2020-12-30
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The frequency of the chronic obstructive pulmonary disease(COPD) acute exacerbation.	one year	Record the frequency of COPD acute exacerbation within one year

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Emergency Department, Xinqiao Hospital, Third Military Medical University; 🇨🇳 Chongqing, China