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Randomized Controlled Study of Programmed Weaning From NIV for AECOPD

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06014034
Enrollment
80
Registered
2023-08-28
Start date
2023-05-12
Completion date
2026-12-31
Last updated
2026-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Exacerbation of COPD

Keywords

noninvasive mechanical ventilation

Brief 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.

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.).

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.

Sponsors

Peking University Third Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Complete evacuation time of non-invasive ventilationAt the end of non-invasive ventilation,through study completion, an average of 11 daysfrom 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

MeasureTime frameDescription
Time in the ICUAt the end of therapy in ICU,through study completion, an average of 14 daysfrom the start of the patient stay in ICU to the day leave from ICU
length of stayAt the end of therapy in hospital, through study completion, an average of 20 daysfrom the start of the patient stay in hospital to leave from hospital
Failure rate of non-invasive ventilationAt the end of therapy in hospital, an average of 20 daysfailure of non-invasive ventilation is defined as a patient requiring endotracheal intubation to invasive ventilation or death

Countries

China

Contacts

PRINCIPAL_INVESTIGATORQingtao Zhou

Peking University Third Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 12, 2026