The Clinical Application and Popularization of Portable Home Noninvasive Ventilator

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

The Clinical Application and Popularization of Portable Home Noninvasive Ventilator

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03238339
• Other study ID #: cstc2016shmszx130034
• Status: Recruiting
• Start date: September 15, 2017
• Est. completion date: December 30, 2020

Study information

• Verified date: December 2019
• Source: Third Military Medical University
• Contact: Hu Mingdong, MD
• Phone: +86-13500362524
• Email: huhanshandd[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

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

Related Conditions & MeSH terms

• Chronic Disease
• Hypercapnic Respiratory Failure
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive
• Respiratory Insufficiency

Locations

Country	Name	City	State
China	Emergency Department, Xinqiao Hospital, Third Military Medical University	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Mingdong Hu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Six Minute Walk Distance		month0,month4,month8,month12
Other	pulmonary arterial pressure		month0,month4,month8,month12
Other	arterial blood gas		month0,month4,month8,month12
Other	routine analysis of blood		month0,month4,month8,month12
Other	The change of cytokines expression	The cytokines including IL8?IL13?TNF-a?INF-r?IFN-??LTB4.	month0,month4,month8,month12
Primary	The frequency of the chronic obstructive pulmonary disease(COPD) acute exacerbation.	Record the frequency of COPD acute exacerbation within one year	one year
Secondary	The first onset time of the chronic obstructive pulmonary disease(COPD) acute exacerbation	Record the first onset time of COPD acute exacerbation	one year
Secondary	The number of hospitalizations due to the chronic obstructive pulmonary disease(COPD) acute exacerbation	Record the number of hospitalizations due to the COPD acute exacerbation	one year