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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Acute Exacerbation of COPD

Intervention / Treatment
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* Other: Programmed Weaning From Noninvasive Mechanical Ventilation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>Programmed Weaning From Noninvasive Mechanical Ventilation | Other: Programmed Weaning From Noninvasive Mechanical Ventilation<br>* 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.<br>|
| No Intervention: Control group<br>this is the traditional withdrawal unit (the attending physician will decide the NIV regimen according to the condition). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | At the end of non-invasive ventilation，through study completion, an average of 11 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time in the ICU | from the start of the patient stay in ICU to the day leave from ICU | At the end of therapy in ICU，through study completion, an average of 14 days | 
| length of stay | from the start of the patient stay in hospital to leave from hospital | At the end of therapy in hospital, through study completion, an average of 20 days | 
| Failure rate of non-invasive ventilation | failure of non-invasive ventilation is defined as a patient requiring endotracheal intubation to invasive ventilation or death | At the end of therapy in hospital, an average of 20 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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noninvasive mechanical ventilation