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

Not Applicable

Recruiting

• Conditions: Acute Respiratory Distress Syndrome
• Interventions: Device: APRV. General Electric Healthcare Engstrom ventilator system; Device: Conventional. General Electric Healthcare Engstrom ventilator system

• Registration Number: NCT04221737
• Lead Sponsor: Hospital Civil de Guadalajara

Brief 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).

Detailed 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.

Study Timeline

• Study Start: 2017-07-15
• Study First Submitted: 2020-01-05
• Study First Submitted QC: 2020-01-06
• Study First Posted: 2020-01-09
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-15
• Last Update Posted: 2025-03-19
• Primary Completion: 2025-11
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Time-controlled adaptive APRV	APRV. General Electric Healthcare Engstrom ventilator system	Airway Pressure Release Ventilation with Time-controlled adaptive ventilation method. Allowing for spontaneous breathing.
Conventional ventilation	Conventional. General Electric Healthcare Engstrom ventilator system	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.

Primary Outcome Measures

Name	Time	Method
Mechanical ventilation free days	28 days

Secondary Outcome Measures

Name	Time	Method
All causes mortality	28 days
Tracheostomy rate	28 days
ICU length of stay	28 days
Hospital length of stay	60 days
Average expiratory time	7 days	Measured in seconds
oxygen partial pressure (pO2)	7 days
Average of prone position sessions	7 days
Mean airway pressure, peak airway pressure, maximum P high	7 days	Measured in cmH20
Rate of neuromuscular blocking agents utilization	7 days
Prone position rate	7 days
Minute ventilation	7 days
pCO2 (carbon dioxide partial pressure)	7 days
Richmond Sedation-Agitation Scale	7 days	Range from -5 (unarousable) to +4 (combative)
Mean arterial pressure	7 days
Maximum dosage of vasopressors requirement	7 days
Average dose of propofol use	7 days
Rate of recruitment maneuvers	7 days

Trial Locations

Locations (1)

Hospital Civil Fray Antonio Alcalde; 🇲🇽 Guadalajara, Jalisco, Mexico