Early Use of Airway Pressure Release Ventilation (APRV) in Patients With Acute Respiratory Distress Syndrome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 150
- Locations
- 2
- Primary Endpoint
- Mechanical ventilation free days
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Time-controlled adaptive APRV
Airway Pressure Release Ventilation with Time-controlled adaptive ventilation method. Allowing for spontaneous breathing.
Intervention: APRV. General Electric Healthcare Engstrom ventilator system (Device)
Conventional ventilation
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.
Intervention: Conventional. General Electric Healthcare Engstrom ventilator system (Device)
Outcomes
Primary Outcomes
Mechanical ventilation free days
Time Frame: 28 days
Secondary Outcomes
- 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)
- oxygen partial pressure (pO2)(7 days)
- Average of prone position sessions(7 days)
- Mean airway pressure, peak airway pressure, maximum P high(7 days)
- 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)
- 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)
Investigators
Miguel Á Ibarra-Estrada
Principal investigator
Hospital Civil de Guadalajara