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NCT Number: NCT04221737

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

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).

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Civil Fray Antonio Alcalde

Guadalajara, Jalisco, 44280, Mexico

Location status: Recruiting

Location contact

Arnulfo López-Pulgarín, MD

SUB_INVESTIGATOR

Guadalupe Aguirre, Dr

CONTACT

[email protected]

Guadalupe Aguirre-Avalos, MD

SUB_INVESTIGATOR

Miguel Ibarra, Dr

CONTACT

[email protected]

3317593502

Quetzalcóatl Chávez-Peña, MD

SUB_INVESTIGATOR

Yessica García-Salas, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

    Time frame: 7 days

    Measured in cmH20

  5. Average expiratory time

    Time frame: 7 days

    Measured in seconds

  6. Minute ventilation

    Time frame: 7 days

  7. oxygen partial pressure (pO2)

    Time frame: 7 days

  8. pCO2 (carbon dioxide partial pressure)

    Time frame: 7 days

  9. Mean arterial pressure

    Time frame: 7 days

  10. Maximum dosage of vasopressors requirement

    Time frame: 7 days

  11. Richmond Sedation-Agitation Scale

    Time frame: 7 days

    Range from -5 (unarousable) to +4 (combative)

  12. Average dose of propofol use

    Time frame: 7 days

  13. Rate of neuromuscular blocking agents utilization

    Time frame: 7 days

  14. Prone position rate

    Time frame: 7 days

  15. Average of prone position sessions

    Time frame: 7 days

  16. Rate of recruitment maneuvers

    Time frame: 7 days

  17. Tracheostomy rate

    Time frame: 28 days

Study contacts

Contact information is provided by the study sponsor or research team.

Guadalupe Aguirre-Avalos, Dr

CONTACT

[email protected]

Miguel Ibarra-Estrada, Dr

CONTACT

[email protected]

3317593502

Sponsors and collaborators

Lead sponsor

Hospital Civil de Guadalajara

Other

Registry information

Official study title

Early Use of Airway Pressure Release Ventilation (APRV) in Patients With Acute Respiratory Distress Syndrome

Important dates

Study start
2017
Primary completion
2025
Study completion
2026
First posted
Jan 9, 2020
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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