The Clinical Application and Popularization of Portable Home Noninvasive Ventilator

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

• Study Contact: Name: Hu Mingdong, MD; Phone Number: +86-13500362524; Email: huhanshandd@163.com

Study Locations

• China
  • Chongqing, China
    • Recruiting
    • Emergency Department, Xinqiao Hospital, Third Military Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The subjects were selected from the Department of respiration, Xinqiao Hospital of Chongqing city.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
The Portable Home Noninvasive Ventilator treatment group; The patients maintain a stable COPD regimen, and on the basis of conventional home oxygen therapy, a portable, wearable, non-invasive ventilator will be used.
Routine home oxygen therapy group; The patient maintained a stable COPD regimen and conventional home oxygen therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The frequency of the chronic obstructive pulmonary disease(COPD) acute exacerbation.	Record the frequency of COPD acute exacerbation within one year	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The first onset time of the chronic obstructive pulmonary disease(COPD) acute exacerbation	Record the first onset time of COPD acute exacerbation	one year
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Six Minute Walk Distance		month0,month4,month8,month12
pulmonary arterial pressure		month0,month4,month8,month12
arterial blood gas		month0,month4,month8,month12
routine analysis of blood		month0,month4,month8,month12
The change of cytokines expression	The cytokines including IL8、IL13、TNF-a、INF-r、IFN-γ、LTB4.	month0,month4,month8,month12

Collaborators and Investigators

• Sponsor: Mingdong Hu

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2017
• Primary Completion (Anticipated): December 30, 2020
• Study Completion (Anticipated): December 30, 2020

Study Registration Dates

• First Submitted: July 31, 2017
• First Submitted That Met QC Criteria: July 31, 2017
• First Posted (Actual): August 3, 2017

Study Record Updates

• Last Update Posted (Actual): December 23, 2019
• Last Update Submitted That Met QC Criteria: December 20, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Pulmonary Disease, Chronic Obstructive; Respiratory Insufficiency; Oxygen Inhalation Therapy; Noninvasive Ventilation
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Disease Attributes; Lung Diseases, Obstructive; Lung Diseases; Pulmonary Disease, Chronic Obstructive; Respiratory Insufficiency; Chronic Disease
• Other Study ID Numbers: cstc2016shmszx130034

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No