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NCT Number: NCT06014034

Randomized Controlled Study of Programmed Weaning From NIV for AECOPD

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Acute Exacerbation of COPD

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University Third Hospita

Beijing, Beijing Municipality, 100191, China

About this study

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.).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Programmed Weaning From Noninvasive Mechanical Ventilation

Other

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Time in the ICU

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

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

  2. length of stay

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

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

  3. Failure rate of non-invasive ventilation

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

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

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Official study title

Randomized Controlled Study of Programmed Weaning From Noninvasive Mechanical Ventilation for Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 28, 2023
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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