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

Primary Purpose

Acute Exacerbation of COPD

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Programmed Weaning From Noninvasive Mechanical Ventilation
Sponsored by
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Exacerbation of COPD focused on measuring noninvasive mechanical ventilation

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Peking University Third HospitaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Study group

Control group

Arm Description

Programmed Weaning From Noninvasive Mechanical Ventilation

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time in the ICU
from the start of the patient stay in ICU to the day leave from ICU
length of stay
from the start of the patient stay in hospital to leave from hospital
Failure rate of non-invasive ventilation
failure of non-invasive ventilation is defined as a patient requiring endotracheal intubation to invasive ventilation or death

Full Information

First Posted
August 9, 2023
Last Updated
August 25, 2023
Sponsor
Peking University Third Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06014034
Brief Title
Randomized Controlled Study of Programmed Weaning From Noninvasive Mechanical Ventilation for Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Official Title
Randomized Controlled Study of Programmed Weaning From Noninvasive Mechanical Ventilation for Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 12, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University Third Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Exacerbation of COPD
Keywords
noninvasive mechanical ventilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Experimental
Arm Description
Programmed Weaning From Noninvasive Mechanical Ventilation
Arm Title
Control group
Arm Type
No Intervention
Arm Description
this is the traditional withdrawal unit (the attending physician will decide the NIV regimen according to the condition).
Intervention Type
Other
Intervention Name(s)
Programmed Weaning From Noninvasive Mechanical Ventilation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Complete evacuation time of non-invasive ventilation
Description
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
Time Frame
At the end of non-invasive ventilation,through study completion, an average of 11 days
Secondary Outcome Measure Information:
Title
Time in the ICU
Description
from the start of the patient stay in ICU to the day leave from ICU
Time Frame
At the end of therapy in ICU,through study completion, an average of 14 days
Title
length of stay
Description
from the start of the patient stay in hospital to leave from hospital
Time Frame
At the end of therapy in hospital, through study completion, an average of 20 days
Title
Failure rate of non-invasive ventilation
Description
failure of non-invasive ventilation is defined as a patient requiring endotracheal intubation to invasive ventilation or death
Time Frame
At the end of therapy in hospital, an average of 20 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Feifan Zhao
Phone
+86-10-82265562
Email
112947952@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Qingtao Zhou
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qingtao Zhou
Organizational Affiliation
Peking University Third Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Third Hospita
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qingtao Zhou, MD
Phone
86-10-82265562
Email
zhouqingtaobysy@sina.com
First Name & Middle Initial & Last Name & Degree
Qingtao Zhou, MD

12. IPD Sharing Statement

Learn more about this trial

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

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