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Active, not recruitingNCT06014034Updated Jun 11, 2026

Randomized Controlled Study of Programmed Weaning From NIV for AECOPD

An interventional study of Programmed Weaning From Noninvasive Mechanical Ventilation in Acute Exacerbation of COPD, sponsored by Peking University Third Hospital. Active, not recruiting at 1 site in China. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-06-11.

Sponsored by Peking University Third Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
40 Years and older
Sex
All
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Study 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 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.).

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Conditions studied

  • Acute Exacerbation of COPD

Keywords

  • noninvasive mechanical ventilation
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In context

Lead sponsor

Peking University Third Hospital is the lead sponsor of 735 studies on the registry; 262 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Study group

    Programmed Weaning From Noninvasive Mechanical Ventilation

    Other: Programmed Weaning From Noninvasive Mechanical Ventilation

  • No intervention
    Control group

    this is the traditional withdrawal unit (the attending physician will decide the NIV regimen according to the condition).

Interventions

  • OtherProgrammed Weaning From Noninvasive Mechanical Ventilation

    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.

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What researchers measure

Primary outcomes

  1. 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

    Time frame: At the end of non-invasive ventilation,through study completion, an average of 11 days

Secondary outcomes

  1. Time in the ICU

    from the start of the patient stay in ICU to the day leave from ICU

    Time frame: At the end of therapy in ICU,through study completion, an average of 14 days

  2. length of stay

    from the start of the patient stay in hospital to leave from hospital

    Time frame: At the end of therapy in hospital, through study completion, an average of 20 days

  3. Failure rate of non-invasive ventilation

    failure of non-invasive ventilation is defined as a patient requiring endotracheal intubation to invasive ventilation or death

    Time frame: At the end of therapy in hospital, an average of 20 days

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Study locations

1 site
  • Peking University Third Hospita
    Beijing, Beijing Municipality 100191, China
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06014034
Lead sponsor
Peking University Third Hospital
Responsible party
Sponsor
First posted
Aug 28, 2023
Start date
May 12, 2023
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Jun 11, 2026

Study contacts

Qingtao Zhou
principal investigator · Peking University Third Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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