Randomized Controlled Study of Programmed Weaning From NIV for AECOPD

NCT06014034 | Recruiting

• 1 other identifier: Y75505-04
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Exacerbation of COPD

Keywords

noninvasive mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Time in the ICU

  At the end of therapy in ICU，through study completion, an average of 14 days

• length of stay

  At the end of therapy in hospital, through study completion, an average of 20 days

• Failure rate of non-invasive ventilation

  At the end of therapy in hospital, an average of 20 days

Study Arms (2)

Study group

EXPERIMENTAL

Programmed Weaning From Noninvasive Mechanical Ventilation

Other: Programmed Weaning From Noninvasive Mechanical Ventilation

Control group

NO INTERVENTION

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

Interventions

Programmed Weaning From Noninvasive Mechanical Ventilation 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.

Study group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospita

Beijing, Beijing Municipality, 100191, China

RECRUITING

Study Officials

• Qingtao Zhou

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Feifan Zhao

CONTACT

+86-10-82265562; 112947952@qq.com

Qingtao Zhou

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2023
• First Posted: August 28, 2023
• Study Start: May 12, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 22, 2025

Record last verified: 2024-11

Locations

CN (1)