PHARLAP-RCT (Permissive Hypercapnia, Alveolar Recruitment and Low Airway Pressure – Randomised Controlled Trial)

pharlap-rct

The PHARLAP-RCT was 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) patients across Australia and New Zealand.

Goal: PHARLAP was a ventilation strategy designed to combine Tidal volume (Vt) and plateau pressure (Pplat) limitation with a comprehensive open lung strategy. The study investigated the clinical efficacy of the PHARLAP strategy compared to standard mechanical ventilation in ARDS patients across Australia and New Zealand. The primary outcome was ventilator free days at day 28. In addition, physiological, inflammatory, clinical and economic outcome variables were compared between both groups. In a prospective, multi-centre, randomised controlled trial we planned to enrol 340 adult patients who had developed ARDS within the past 48 hours and randomly allocate them to either the PHARLAP or a control ventilation strategy.

Rationale: ARDS is an inflammatory condition of the lung associated with devastatingly high morbidity and mortality. Vt and Pplat minimisation had been shown to decrease mortality in these patients.

Clinical Trial Registration: ClinicalTrials.gov Identifier NCT01667146

Study Completed: The PHARLAP-RCT commenced in 2012. The enrolment target was 340 patients across Australia and New Zealand. Patient recruitment was halted in 2017 by the PHARLAP Management Committee after publication of the Alveolar Recruitment Trial (Cavalcanti et al. Effect of Lung Recruitment and Titrated Positive End-Expiratory Pressure (PEEP) vs Low PEEP on Mortality in Patients With Acute Respiratory Distress Syndrome: A Randomized Clinical Trial. JAMA 2017; 318: 1335-1345).

Contact: For further information about this study, please contact the Co-Chairs of the PHARLAP-RCT Management Committee, Professors Carol Hodgson and Alistair Nichol, by email.

Publications:

Hodgson C, Cooper DJ, Arabi Y, Bennett V, Bersten A, Brickell K, Davies A, Fahey C, Fraser J, McGuinness S, Murray L, Parke R, Tuxen D, Vallance S, Young M, Nichol AD. Permissive Hypercapnia, Alveolar Recruitment and Low Airway Pressure (PHARLAP): a protocol for a phase 2 trial in patients with acute respiratory distress syndrome. Crit Care Resusc 2018;20:139-49.

PHARLAP Study Statistical Analysis Plan Version 1, 22 August 2017