The Clinical Application and Popularization of Portable Home Noninvasive Ventilator

NCT03238339 | Unknown

• 1 other identifier: cstc2016shmszx130034
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Disease, Chronic Obstructive; Hypercapnic Respiratory Failure

Keywords

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

Outcome Measures

Primary Outcomes (1)

• The frequency of the chronic obstructive pulmonary disease(COPD) acute exacerbation.

  Record the frequency of COPD acute exacerbation within one year

  one year

Secondary Outcomes (2)

• The first onset time of the chronic obstructive pulmonary disease(COPD) acute exacerbation

  one year

• The number of hospitalizations due to the chronic obstructive pulmonary disease(COPD) acute exacerbation

  one year

Other Outcomes (5)

• Six Minute Walk Distance

  month0,month4,month8,month12

• pulmonary arterial pressure

  month0,month4,month8,month12

• arterial blood gas

  month0,month4,month8,month12

Study Arms (2)

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.

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mingdong Hu: lead

Study Sites (1)

Emergency Department, Xinqiao Hospital, Third Military Medical University

Chongqing, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders

Central Study Contacts

Hu Mingdong, MD

CONTACT

+86-13500362524; huhanshandd@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: associate chief physician

Study Record Dates

• First Submitted: July 31, 2017
• First Posted: August 3, 2017
• Study Start: September 15, 2017
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: December 23, 2019

Record last verified: 2019-12

Locations

CN (1)