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

Hospital Civil de Guadalajara

Status: Enrolling

Conditions: Acute Respiratory Distress Syndrome

Treatments: Device: Conventional. General Electric Healthcare Engstrom ventilator system; Device: APRV. General Electric Healthcare Engstrom ventilator system

Study type: Interventional

Funder types: Other

Identifiers

NCT04221737

HCG/CEI-0632/17

Details and patient eligibility

About

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).

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

150 participants in 2 patient groups

Conventional ventilation

Active Comparator group

Description:

Protective lung conventional strategy with volume-controlled ventilation (VCV) or pressure-controlled ventilation (PCV) mode, with low tidal volume and adequate positive end expiratory pressure (PEEP) level.

Treatment:

Device: Conventional. General Electric Healthcare Engstrom ventilator system

Time-controlled adaptive APRV

Experimental group

Description:

Airway Pressure Release Ventilation with Time-controlled adaptive ventilation method. Allowing for spontaneous breathing.

Treatment:

Device: APRV. General Electric Healthcare Engstrom ventilator system