Early Use of Airway Pressure Release Ventilation (APRV) in ARDS

Last updated: March 15, 2025
Sponsor: Hospital Civil de Guadalajara
Overall Status: Active - Recruiting

Phase

N/A

Condition

Respiratory Failure

Acute Respiratory Distress Syndrome (Ards)

Lung Injury

Treatment

Conventional. General Electric Healthcare Engstrom ventilator system

APRV. General Electric Healthcare Engstrom ventilator system

Clinical Study ID

NCT04221737
HCG/CEI-0632/17
  • Ages 18-80
  • All Genders

Study Summary

Airway pressure release ventilation (APRV) is a time-cycled, pressure controlled, intermittent mandatory ventilation mode with extreme inverse I:E ratios. Currently it is considered as a non-conventional ventilatory mode. The investigators aim to compare APRV with conventional mechanical ventilation (MV) in patients with acute respiratory distress syndrome (ARDS).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Acute respiratory distress syndrome, according to the Berlin definition of ARDS,with adjusted pO2/FiO2 for altitude <300, and less than 48 h of endotrachealmechanical ventilation

Exclusion

Exclusion Criteria:

  • Pregnancy

  • Less than 18 years-old

  • Expected duration of mechanical ventilation less than 48 h

  • Preexisting conditions with an expected 3-month mortality exceeding 50%

  • Concurrent chemotherapy

  • Confirmed intracranial hypertension

  • Catastrophic cranial trauma or neuromuscular disorders that are known to prolongmechanical ventilation

  • Pneumothorax at enrollment (resolved or not)

  • Do-not-resuscitate order

Study Design

Total Participants: 150
Treatment Group(s): 2
Primary Treatment: Conventional. General Electric Healthcare Engstrom ventilator system
Phase:
Study Start date:
July 15, 2017
Estimated Completion Date:
January 31, 2026

Study Description

Despite the advances in technology and ventilatory modes, mortality of ARDS is still around 40%. Besides prone positioning, the best approach of management is low tidal volume ventilation (LTV). This 'protective ventilation' strategy is not aways effective to improve oxygenation and is associated with an increased requirement of sedation and neuromuscular blocking agents, which increase length of stay and morbidity. APRV is a ventilatory mode based on relatively high and sustained continuous positive pressure, combined with a short phase of release to allow carbon dioxide removal. It also allows unrestricted spontaneous breathing throughout respiration, independent of the ventilator cycle. Providing sustained inflation while limiting duration and frequency of release phase permits limiting volume loss, resulting in progressive and improved alveolar recruitment, an increased alveolar surface area available for gas exchange and improved ventilation-perfusion matching.

In this multi-center, prospective, randomized, controlled, open trial, the investigators aim to compare the effects and safety of the early application of time-controlled adaptive method of APRV and conventional ventilation with LTV strategy in patients with severe to moderate ARDS.

Connect with a study center

  • Hospital Civil Fray Antonio Alcalde

    Guadalajara, Jalisco 44280
    Mexico

    Active - Recruiting

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