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The Clinical Application and Popularization of Portable Home Noninvasive Ventilator

NCT ID: NCT03238339

Last Updated: 2019-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-15

Study Completion Date

2020-12-30

Brief Summary

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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

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Conditions

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Pulmonary Disease, Chronic Obstructive Hypercapnic Respiratory Failure

Keywords

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Pulmonary Disease, Chronic Obstructive Respiratory Insufficiency Oxygen Inhalation Therapy Noninvasive Ventilation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Routine home oxygen therapy group

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mingdong Hu

OTHER

Sponsor Role lead

Responsible Party

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Mingdong Hu

associate chief physician

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Emergency Department, Xinqiao Hospital, Third Military Medical University

Chongqing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hu Mingdong, MD

Role: CONTACT

Phone: +86-13500362524

Email: [email protected]

Facility Contacts

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HU MINGDONG, MD

Role: primary

Other Identifiers

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cstc2016shmszx130034

Identifier Type: -

Identifier Source: org_study_id