Clinical trial NCT06014034: Randomized Controlled Study of Programmed Weaning From NIV for AECOPD
Official title: Randomized Controlled Study of Programmed Weaning From Noninvasive Mechanical Ventilation for Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Exacerbation of COPD
Keywords: noninvasive mechanical ventilation
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2023-08-28
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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) or return of time to normal ventilation for patients with a home non-invasive ventilator prior to acute exacerbation. Secondary study endpoints include length of stay, stay and failure of non-invasive ventilation (failure of non-invasive ventilation was defined as the patient requiring endotracheal intubation to invasive ventilation or death).

Eligibility criteria: 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
* Mechanical ventilation for endotracheal intubation and cardiopulmonary resuscitation were disagreed

Primary outcomes:
measure: Complete evacuation time of non-invasive ventilation
timeFrame: At the end of non-invasive ventilation，through study completion, an average of 11 days
Secondary outcomes:
measure: Time in the ICU
timeFrame: At the end of therapy in ICU，through study completion, an average of 14 days
measure: length of stay
timeFrame: At the end of therapy in hospital, through study completion, an average of 20 days
measure: Failure rate of non-invasive ventilation
timeFrame: At the end of therapy in hospital, an average of 20 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospita
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Qingtao Zhou
role: PRINCIPAL_INVESTIGATOR
References: