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

Acute Exacerbation of COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06014034
• Other study ID #: Y75505-04
• Status: Recruiting
• Phase: N/A
• Start date: May 12, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: July 2023
• Source: Peking University Third Hospital
• Contact: Feifan Zhao
• Phone: +86-10-82265562
• Email: 112947952[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Exacerbation of COPD
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Programmed 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.

Locations

Country	Name	City	State
China	Peking University Third Hospita	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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