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

ConditionAcute Respiratory Distress Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorHospital Civil de Guadalajara

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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%

Trial design

Design model

Parallel

Treatments tested in this trial

  • APRV. General Electric Healthcare Engstrom ventilator system

    Device

    APRV consist of an extended time at plateau pressure (a continuous positive airway pressure phase) comprising about 90% of the respiratory cycle, while providing very brief releases to enhance carbon dioxide removal. Time-controlled adaptive method requires interpretation of the expiratory flow curve to assess changes in lung elastance and, therefore, set the Time low to optimize carbon dioxide removal, but not at the expense of alveolar derecruitment and instability.

  • Conventional. General Electric Healthcare Engstrom ventilator system

    Device

    Lung protective ventilation consist of delivery of low tidal volumes (4-6 ml/kg PBW), high PEEP enough to avoid de-recruitment, titrated according to ARDSNet PEEP/fraction of inspired oxygen (FiO2) table, while avoiding excessive transpulmonary pressure.

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Conventional ventilationActive comparator 1 intervention
Group B: Time-controlled adaptive APRVExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Mechanical ventilation free days

Time frame
28 days

Secondary outcomes

1

All causes mortality

Time frame
28 days
2

ICU length of stay

Time frame
28 days
3

Hospital length of stay

Time frame
60 days
4

Mean airway pressure, peak airway pressure, maximum P high

Measured in cmH20

Time frame
7 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital Civil de Guadalajara

Lead sponsor

Source ClinicalTrials.gov
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