The PHARLAP-RCT is a prospective, multi-centre, randomised controlled trial of the clinical efficacy of a ventilation strategy (called PHARLAP) compared to standard mechanical ventilation in acute respiratory distress syndrome (ARDS). This trial will be collaboration between Intensive Care Units of the Irish Critical Care- Clinical Trails Group (ICC- CTG) and the Australian and New Zealand Intensive Care Society- Clinical Trials Group (ANZICS-CTG).
ARDS is an inflammatory condition of the lung parenchyma. ARDS is a global problem and despite best supportive care, ARDS is common and associated with significant mortality and morbidity. Any intervention that could potentially impact mortality, time on mechanical ventilation and the need for expensive rescue therapies would have important human, social and financial benefits and warrant investigation.
The study will investigate the clinical efficacy of the PHARLAP strategy compared to standard mechanical ventilation in ARDS patients. In a prospective, multi-centre, randomised controlled trial 340 adult patients in total will be enrolled who have developed ARDS within the past 48 hours and randomly allocate them to either the PHARLAP or a control ventilation strategy.
ICU Patients ≥16 years of age who are i) intubated, ii) within 48 hours of a diagnosis of moderate or severe ARDS based on the Berlin Consensus Conference Criteria (PaO2/FiO2 <200 mmHg) on over 5 cmH2O of PEEP and ii) have received ≤ 5 days of invasive mechanical ventilation.
- Barotrauma (pneumothorax, pneumomediastinum, subcutaneous emphysema or the presence of any intercostal catheter)
- Significant chest trauma i.e. multiple rib fractures
- Active bronchospasm or a history of significant chronic obstructive airway disease or asthma
- Moderate and severe traumatic brain injury, the presence of an intracranial pressure monitor, or any medical condition associated with a clinical suspicion of raised intracranial pressure
- Unstable cardiovascular status defined as sustained heart rate < 40 or > 140 bpm, ventricular tachycardia, SBP < 80 mmHg despite significant vasopressor support
- Lack of consent (treating physician or next of kin)
- Inevitable and imminent death
- Receiving ECMO.