Randomized Controlled Study of Programmed Weaning from NIV for AECOPD

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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Exacerbation of COPD
• Intervention / Treatment: Other: Programmed Weaning From Noninvasive Mechanical Ventilation

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Feifan Zhao; Phone Number: +86-10-82265562; Email: 112947952@qq.com
• Study Contact Backup: Name: Qingtao Zhou

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Recruiting
      • Peking University Third Hospita
      • Contact: Qingtao Zhou, MD; Phone Number: 86-10-82265562; Email: zhouqingtaobysy@sina.com
      • Contact: Qingtao Zhou, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Principal Investigator: Qingtao Zhou, Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: August 9, 2023
• First Submitted That Met QC Criteria: August 25, 2023
• First Posted (Actual): August 28, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 19, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: noninvasive mechanical ventilation
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Chronic Disease; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: Y75505-04

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No