Randomized Controlled Study of Programmed Weaning From NIV for AECOPD

NCT ID: NCT06014034

Last Updated: 2025-01-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-12
• Study Completion Date: 2025-12-31

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).

Conditions

Acute Exacerbation of COPD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study group

Programmed Weaning From Noninvasive Mechanical Ventilation

Group Type: EXPERIMENTAL

Programmed Weaning From Noninvasive Mechanical Ventilation

Intervention Type: OTHER

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.

Control group

this is the traditional withdrawal unit (the attending physician will decide the NIV regimen according to the condition).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Qingtao Zhou

Role: PRINCIPAL_INVESTIGATOR

Peking University Third Hospital

Locations

Peking University Third Hospita

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Feifan Zhao

Role: CONTACT

112947952@qq.com

+86-10-82265562

Qingtao Zhou

Role: CONTACT

Facility Contacts

Qingtao Zhou, MD

Role: primary

zhouqingtaobysy@sina.com

86-10-82265562

Other Identifiers

Y75505-04

Identifier Type: -

Identifier Source: org_study_id