Pulmonary Disease, Chronic ObstructiveNCT03238339
The Clinical Application and Popularization of Portable Home Noninvasive Ventilator
An observational study of Pulmonary Disease, Chronic Obstructive and Hypercapnic Respiratory Failure, run by Mingdong Hu at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Hypercapnic Respiratory Failure
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2017to 30 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The subjects were selected from the Department of respiration, Xinqiao Hospital of Chongqing city.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Emergency Department, Xinqiao Hospital, Third Military Medical University
Chongqing
HU MINGDONG, MD
About this study
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.
- Keywords
- Pulmonary Disease, Chronic Obstructive, Respiratory Insufficiency, Oxygen Inhalation Therapy, Noninvasive Ventilation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
The frequency of the chronic obstructive pulmonary disease(COPD) acute exacerbation.
Record the frequency of COPD acute exacerbation within one year
Measured: one year
Secondary outcomes (2)
The first onset time of the chronic obstructive pulmonary disease(COPD) acute exacerbation
Record the first onset time of COPD acute exacerbation
Measured: 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
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2017
- Study start15 Sep 2017
- Primary completion30 Dec 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mingdong Hu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mingdong Hu, Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03238339
- Sponsor's protocol ID
- cstc2016shmszx130034
- Status last verified
- Dec 2019
- First submitted
- 31 Jul 2017
- Last updated
- 23 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Application and Popularization of Portable Home Noninvasive Ventilator
- ClinicalTrials.gov ID
- NCT03238339
- Acronym / sponsor ID
- cstc2016shmszx130034
- Keywords
- Pulmonary Disease, Chronic Obstructive, Respiratory Insufficiency, Oxygen Inhalation Therapy, Noninvasive Ventilation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mingdong HuUniversity, hospital or other
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 3 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The subjects were selected from the Department of respiration, Xinqiao Hospital of Chongqing city.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The frequency of the chronic obstructive pulmonary disease(COPD) acute exacerbation.
Time frame: one year
Record the frequency of COPD acute exacerbation within one year
2 secondary outcomes
The first onset time of the chronic obstructive pulmonary disease(COPD) acute exacerbation
Time frame: one year
The number of hospitalizations due to the chronic obstructive pulmonary disease(COPD) acute exacerbation
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, Chronic Obstructive and Hypercapnic Respiratory Failure, run by Mingdong Hu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hu Mingdong, MD (+86-13500362524, huhanshandd@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The frequency of the chronic obstructive pulmonary disease(COPD) acute exacerbation. (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2019.