Acute Exacerbation of COPDNCT06014034
Randomized Controlled Study of Programmed Weaning From NIV for AECOPD
A study testing Programmed Weaning From Noninvasive Mechanical Ventilation in people with Acute Exacerbation of COPD, run by Peking University Third Hospital at 1 site in China.
Trial summary
Purpose of research:to explore a reasonable programmed withdrawal process of noninvasive ventilation and thereby reduce the duration of noninvasive mechanical ventilation in patients with acute exacerbations of chronic obstructive pulmonary disease. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Acute Exacerbation of COPD
- What is being tested?
- Programmed Weaning From Noninvasive Mechanical Ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 12 May 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- It is defined that in patients with acute exacerbation of chronic obstructive pulmonary disease, the arterial blood gas analysis was decompensation of respiratory acidosis, and the pH value was 7.20-7.35
- Non-invasive mechanical ventilation was performed and it was well tolerated
Who cannot join
- younger than 40 years old
- pregnancy
- Human immunodeficiency virus (HIV) antibody was positive
- Hemodynamic instability
- Long-term use of home non-invasive ventilators
- Mechanical ventilation for endotracheal intubation and cardiopulmonary resuscitation were disagreed
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospita
Beijing, Beijing Municipality, 100191
About this study
Official title: Randomized Controlled Study of Programmed Weaning From Noninvasive Mechanical Ventilation for Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Purpose of research:to explore a reasonable programmed withdrawal process of noninvasive ventilation and thereby reduce the duration of noninvasive mechanical ventilation in patients with acute exacerbations of chronic obstructive pulmonary disease.
Read the detailed description
This is a single-center, prospective, randomized controlled study. The study subjects were patients with acute exacerbation of chronic obstructive pulmonary disease admitted to the intensive care unit, who were randomized into the study group, that is, the programmed withdrawal unit, and the control group was the traditional withdrawal unit (the attending physician decided the NIV regimen according to the condition). The primary study endpoints of the trial were complete evacuation of noninvasive ventilation (i. e. from the start of the patient to noninvasive ventilation) . Secondary study endpoints include length of stay in ICU, length of stay in hospital and failure of non-invasive ventilation (failure of non-invasive ventilation was defined as the patient underwent NIV again within 48 hours after being weaned off the ventilator;During NIV, endotracheal intubation was required, and invasive mechanical ventilation was used instead;The patient could not discontinue NIV completely and needed to use home non-invasive ventilation; The patient died.).
- Conditions
- Acute Exacerbation of COPD
- Being tested
- Programmed Weaning From Noninvasive Mechanical Ventilation
- Keywords
- noninvasive mechanical ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Programmed Weaning From Noninvasive Mechanical VentilationOther
Programmed withdrawal unit: daily morning review arterial blood gas analysis (since the 2nd, daily morning stop non-invasive ventilation 1 hours, 2 hours, 3 hours, 4 hours after check arterial blood gas analysis), blood gas results suggest respiratory acidosis compensatory period (pH value greater than 7.35) can reduce daily noninvasive ventilation time, namely the noninvasive ventilation use time for 24 hours, 20 hours, the third day 16 hours, the fourth 12 hours, fifth day 8 hours. If ABG indicates still acid decompensation, continue the non-invasive ventilation regimen of the previous day. If noninvasive ventilation failed, invasive mechanical ventilation was performed.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Programmed Weaning From Noninvasive Mechanical Ventilation Receives: Other: Programmed Weaning From Noninvasive Mechanical Ventilation |
| Control group | No intervention | this is the traditional withdrawal unit (the attending physician will decide the NIV regimen according to the condition). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete evacuation time of non-invasive ventilation
from the start of the patient to the absence of noninvasive ventilation or return to the level of normal ventilation time for patients with non-invasive ventilation on a home non-invasive ventilator before acute exacerbation
Measured: At the end of non-invasive ventilation，through study completion, an average of 11 days
Secondary outcomes (3)
Time in the ICU
from the start of the patient stay in ICU to the day leave from ICU
Measured: At the end of therapy in ICU，through study completion, an average of 14 days
length of stay
from the start of the patient stay in hospital to leave from hospital
Measured: At the end of therapy in hospital, through study completion, an average of 20 days
Failure rate of non-invasive ventilation
failure of non-invasive ventilation is defined as a patient requiring endotracheal intubation to invasive ventilation or death
Measured: At the end of therapy in hospital, an average of 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start12 May 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Exacerbation of COPDStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qingtao Zhou, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06014034
- Sponsor's protocol ID
- Y75505-04
- Status last verified
- Apr 2026
- First submitted
- 9 Aug 2023
- Last updated
- 11 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study of Programmed Weaning From Noninvasive Mechanical Ventilation for Acute Exacerbation of Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT06014034
- Acronym / sponsor ID
- Y75505-04
- Conditions
- Acute Exacerbation of COPD
- Keywords
- noninvasive mechanical ventilation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 12 May 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 28 Aug 2023 (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.
Purpose of research:to explore a reasonable programmed withdrawal process of noninvasive ventilation and thereby reduce the duration of noninvasive mechanical ventilation in patients with acute exacerbations of chronic obstructive pulmonary disease.
Detailed description
This is a single-center, prospective, randomized controlled study. The study subjects were patients with acute exacerbation of chronic obstructive pulmonary disease admitted to the intensive care unit, who were randomized into the study group, that is, the programmed withdrawal unit, and the control group was the traditional withdrawal unit (the attending physician decided the NIV regimen according to the condition). The primary study endpoints of the trial were complete evacuation of noninvasive ventilation (i. e. from the start of the patient to noninvasive ventilation) . Secondary study endpoints include length of stay in ICU, length of stay in hospital and failure of non-invasive ventilation (failure of non-invasive ventilation was defined as the patient underwent NIV again within 48 hours after being weaned off the ventilator;During NIV, endotracheal intubation was required, and invasive mechanical ventilation was used instead;The patient could not discontinue NIV completely and needed to use home non-invasive ventilation; The patient died.).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Other: Programmed Weaning From Noninvasive Mechanical VentilationProgrammed Weaning From Noninvasive Mechanical Ventilation |
| Control group | No intervention | –this is the traditional withdrawal unit (the attending physician will decide the NIV regimen according to the condition). |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- It is defined that in patients with acute exacerbation of chronic obstructive pulmonary disease, the arterial blood gas analysis was decompensation of respiratory acidosis, and the pH value was 7.20-7.35
- Non-invasive mechanical ventilation was performed and it was well tolerated
Key exclusion criteria (6 listed)
- younger than 40 years old
- pregnancy
- Human immunodeficiency virus (HIV) antibody was positive
- Hemodynamic instability
- Long-term use of home non-invasive ventilators
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Programmed Weaning From Noninvasive Mechanical VentilationProgrammed withdrawal unit: daily morning review arterial blood gas analysis (since the 2nd, daily morning stop non-invasive ventilation 1 hours, 2 hours, 3 hours, 4 hours after check arterial blood gas analysis), blood gas results suggest respiratory acidosis compensatory period (pH value greater than 7.35) can reduce daily noninvasive ventilation time, namely the noninvasive ventilation use time for 24 hours, 20 hours, the third day 16 hours, the fourth 12 hours, fifth day 8 hours. If ABG indicates still acid decompensation, continue the non-invasive ventilation regimen of the previous day. If noninvasive ventilation failed, invasive mechanical ventilation was performed. | Other | Study group |
Primary outcome
Complete evacuation time of non-invasive ventilation
Time frame: At the end of non-invasive ventilation，through study completion, an average of 11 days
from the start of the patient to the absence of noninvasive ventilation or return to the level of normal ventilation time for patients with non-invasive ventilation on a home non-invasive ventilator before acute exacerbation
3 secondary outcomes
Time in the ICU
Time frame: At the end of therapy in ICU，through study completion, an average of 14 days
length of stay
Time frame: At the end of therapy in hospital, through study completion, an average of 20 days
Failure rate of non-invasive ventilation
Time frame: At the end of therapy in hospital, an average of 20 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
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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.
Qingtao Zhou principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Programmed Weaning From Noninvasive Mechanical Ventilation in people with Acute Exacerbation of COPD, run by Peking University Third Hospital 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 2 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 11 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete evacuation time of non-invasive ventilation (time frame: At the end of non-invasive ventilation，through study completion, an average of 11 days). 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 11 Jun 2026.