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

  • STATUS
    Recruiting
  • End date
    Jan 28, 2026
  • participants needed
    150
  • sponsor
    Hospital Civil de Guadalajara
Updated on 19 February 2024
mechanical ventilation
FIO2
respiratory distress
acute respiratory distress
intermittent mandatory ventilation
airway pressure release ventilation
fraction of inspired oxygen (fio2)

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).

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.

Details
Condition Pulmonary Disease, ADULT RESPIRATORY DISTRESS SYNDROME
Age 18-80 years
Treatment APRV. General Electric Healthcare Engstrom ventilator system, Conventional. General Electric Healthcare Engstrom ventilator system
Clinical Study IdentifierNCT04221737
SponsorHospital Civil de Guadalajara
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

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 endotracheal mechanical ventilation

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 prolong mechanical ventilation
Pneumothorax at enrollment (resolved or not)
Do-not-resuscitate order
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