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

Not Applicable

Recruiting

• Conditions: Acute Exacerbation of COPD
• Interventions: Other: Programmed Weaning From Noninvasive Mechanical Ventilation

• Registration Number: NCT06014034
• Lead Sponsor: Peking University Third Hospital

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).

Study Timeline

• Study Start: 2023-05-12
• Status Verified: 2023-07
• Study First Submitted: 2023-08-09
• Study First Submitted QC: 2023-08-25
• Last Update Submitted: 2023-08-25
• Study First Posted: 2023-08-28
• Last Update Posted: 2023-08-28
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group	Programmed Weaning From Noninvasive Mechanical Ventilation	Programmed Weaning From Noninvasive Mechanical Ventilation

Primary Outcome Measures

Name	Time	Method
Complete evacuation time of non-invasive ventilation	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 Outcome Measures

Name	Time	Method
length of stay	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
Time in the ICU	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
Failure rate of non-invasive ventilation	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

Trial Locations

Locations (1)

Peking University Third Hospita; 🇨🇳 Beijing, Beijing, China