A Multicenter, Random Control Study :Early Use of Airway Pressure Release Ventilation (APRVplus) Protocol in ARDS

Last updated: April 10, 2024
Sponsor: West China Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lung Injury

Respiratory Failure

Acute Respiratory Distress Syndrome (Ards)

Treatment

APRVplus protocol

Low tidal volume ventilation

Clinical Study ID

NCT03549910
Huaxi ICU-APRV
  • Ages 18-85
  • All Genders

Study Summary

Animal experimentals have shown that the more physiology-driven airway pressure release ventilation (APRV) methodologies in ARDS may significantly improve alveolar recruitment and gas exchange, increased homogeneity, and attenuate lung injury, without circulatory depression, as compared with conventional low tial volume lung protective ventilation. our previous single centre,random control study showed that clinical benefit for early use of APRV in ARDS. Nonetheless, clinical data on ARDS are still limited, most of them derived from small clinical trials in which variable outdated APRV settings were used, consequently, the findings of these studies were controversial.

Additionally, the previous single-centre,random control study showed that clinical benefit for APRV.Therefore,the investigators are ready to design a multiple centres,random control study to further verify the effect of APRV plus protocol in ARDS.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Moderate and severe acute respiratory distress syndrome,according to the Berlindefinition of ARDS
  • receiving tracheal intubation and mechanical ventilation was no longer than 48 hours

Exclusion

Exclusion Criteria:

  • Pregnancy
  • The expected duration of mechanical ventilation was less than 48 hours
  • Intracranial hypertension (suspected or confirmed)
  • Neuromuscular disorders that are known to prolong the need for mechanical ventilation
  • Known or suspected chronic obstructive pulmonary disease(COPD)
  • Terminal stage of disease
  • Pneumothorax (drained or not)at enrollment
  • Treatment with extracorporeal support (ECMO) at enrollment
  • There was a lack of commitment to life support.

Study Design

Total Participants: 840
Treatment Group(s): 2
Primary Treatment: APRVplus protocol
Phase:
Study Start date:
December 10, 2020
Estimated Completion Date:
December 30, 2024

Study Description

All the patients included will be randomly assigned to receiving APRV plus protocol or low tidal volume ventilation.

Connect with a study center

  • West China Hospital,Sichuan University

    Chengdu, Sichuan 610041
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.