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. 2016 Nov 17;2016(11):CD006667. doi: 10.1002/14651858.CD006667.pub3

PHARLAP Group Investigators.

Trial name or title A Multi‐centre Trial of an Open Lung Strategy Including Permissive Hypercapnia, Alveolar Recruitment and Low Airway Pressure in Patients With Acute Respiratory Distress Syndrome
Methods Prospective, multi‐centre, parallel‐group RCT
Participants Participants considered for this trial are those in mechanical ventilation with diagnosis of ARDS < 72 hours
Participants will be excluded if they are younger than 18 years old, in use of vasopressor drugs in increasing doses over the past 2 hours or mean arterial blood pressure < 65 mmHg, presence of any contraindication to hypercapnia, undrained pneumothorax or subcutaneous emphysema and lack of consent from participant's surrogate for participation
Interventions Intervention group: pressure control ventilation to maintain tidal volume 4‐6 mL/kg and plateau pressure ≤ 30 cm H2O while tolerating respiratory acidosis if pH > 7.15; daily staircase recruitment manoeuvre and individualized PEEP titration
Control group: mechanical ventilation based on the ARDSnet protocol using volume control ventilation with tidal volume 6 mL/kg, plateau pressure ≤ 30 cm H2O and FiO2/PEEP titration according to FiO2/PEEP/oxygen saturation combination chart. This has been modified for Australian and New Zealand practice to allow pressure control and pressure support ventilation
Outcomes Primary: number of ventilator‐free days at day 28 post randomization
Secondary

  • PaO2/FiO2 ratio and static lung compliance

  • Baseline to day 3 change in IL‐8 and IL‐6 concentrations in bronchoalveolar lavage and plasma

  • Incidence of severe hypotension

  • Incidence of barotrauma

  • Use of rescue therapies for severe hypoxaemia ‐ inhaled nitric oxide, inhaled prostacyclin, prone positioning, high‐frequency oscillatory ventilation and extracorporeal membrane oxygenation (ECMO)

  • Mortality: ICU discharge, hospital discharge, 28 days, 90 days and 6 months

  • ICU and hospital length of stay

  • Incidence of AKI

  • Quality of life assessment: 6 months post randomization

  • Cost‐effectiveness analysis
Starting date August 2012
Contact information carol.hodsgon@monash.edu
Notes ClinicalTrials.gov Identifier: NCT01667146

AKI = acute kidney injury; ARDS = acute respiratory distress syndrome; ECMO = extracorporeal membrane oxygenation; FiO2 = fraction of inspired oxygen; ICU = intensive care unit; IL = interleukin; PaO2 = partial pressure of oxygen; PEEP = positive end‐expiratory pressure; RCT = randomized controlled trial.