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Maximal Recruitment Open Lung Ventilation in Acute Respiratory Distress Syndrome (PHARLAP): A Phase II, Multicenter, Randomized, Controlled Trial.

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RATIONALE Open lung ventilation strategies have been recommended in patients with acute respiratory distress syndrome (ARDS). OBJECTIVE To determine whether a maximal lung recruitment strategy reduces ventilator-free days in patients… Click to show full abstract

RATIONALE Open lung ventilation strategies have been recommended in patients with acute respiratory distress syndrome (ARDS). OBJECTIVE To determine whether a maximal lung recruitment strategy reduces ventilator-free days in patients with ARDS. METHODS A phase II multicenter, randomized, controlled trial in adults with moderate to severe ARDS. Patients received either maximal lung recruitment, titrated positive end expiratory pressure and further tidal volume limitation or control 'protective' ventilation. MEASUREMENTS The primary outcome was ventilator-free days at day 28. Secondary outcomes included mortality, barotrauma, new use of hypoxemic adjuvant therapies, ICU and hospital stay. MAIN RESULTS Enrolment halted on 2nd October 2017 following publication of the Alveolar Recruitment Trial, when 115 of a planned 340 patients had been randomized (57% male, mean age 53.6 years). At 28-days after randomization, there was no difference in ventilator-free days between the maximal lung recruitment and the control ventilation strategies, median [IQR] 16[0-21], n=57 versus 14.5[0-21.5], n=56, P=0.95, mortality 24.6% (n=14/56) versus 26.8% (n=15/56), P=0.79, or the rate of barotrauma 5.2% (n=3/57) versus 10.7% (n=6/56), P=0.32. However, in the intervention group there was reduced use of new hypoxemic adjuvant therapies (i.e. inhaled nitric oxide, extracorporeal membrane oxygenation, prone) (median [IQR] change from baseline 0 (0-1) vs 1 (0-1); P=0.004) and increased rates of new cardiac arrhythmia (n=17, 29% versus n=7, 13%, P=0.03). CONCLUSIONS Compared to control ventilation, maximal lung recruitment did not reduce the duration of ventilation free days or mortality and was associated with increased cardiovascular adverse events but lower use of hypoxemic adjuvant therapies. Clinical trial registration available at www.clinicaltrials.gov, ID: NCT01667146.

Keywords: ventilation; lung ventilation; recruitment; open lung; trial

Journal Title: American journal of respiratory and critical care medicine
Year Published: 2019

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