The Clinical Application and Popularization of Portable Home Noninvasive Ventilator

Mingdong Hu

Status: Unknown

Conditions: Pulmonary Disease, Chronic Obstructive; Hypercapnic Respiratory Failure

Study type: Observational

Funder types: Other

Identifiers

NCT03238339

cstc2016shmszx130034

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

40 participants in 2 patient groups

The Portable Home Noninvasive Ventilator treatment group

Description:

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

Description:

The patient maintained a stable COPD regimen and conventional home oxygen therapy.