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

Sponsor
Peking University Third Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT06014034
Collaborator
(none)
50
1
2
19.7
2.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Programmed Weaning From Noninvasive Mechanical Ventilation
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Randomized Controlled Study of Programmed Weaning From Noninvasive Mechanical Ventilation for Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Actual Study Start Date :
May 12, 2023
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

  1. Complete evacuation time of non-invasive ventilation [At the end of non-invasive ventilation´╝îthrough study completion, an average of 11 days]

    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

  1. Time in the ICU [At the end of therapy in ICU´╝îthrough study completion, an average of 14 days]

    from the start of the patient stay in ICU to the day leave from ICU

  2. length of stay [At the end of therapy in hospital, through study completion, an average of 20 days]

    from the start of the patient stay in hospital to leave from hospital

  3. Failure rate of non-invasive ventilation [At the end of therapy in hospital, an average of 20 days]

    failure of non-invasive ventilation is defined as a patient requiring endotracheal intubation to invasive ventilation or death

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Peking University Third Hospita Beijing Beijing China 100191

Sponsors and Collaborators

  • Peking University Third Hospital

Investigators

  • Principal Investigator: Qingtao Zhou, Peking University Third Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Peking University Third Hospital
ClinicalTrials.gov Identifier:
NCT06014034
Other Study ID Numbers:
  • Y75505-04
First Posted:
Aug 28, 2023
Last Update Posted:
Aug 28, 2023
Last Verified:
Jul 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Peking University Third Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 28, 2023