6/29/23, 1:37 AM PHARLAP Pathway Feedback Search Clinical Topics Home Studies PHARLAP PHARLAP DiseaseAcute respiratory distress syndr Trial question What is the role of maximal recruitment open lung ventilation in patients with ARDS? Study design Multi-center Open label RCT Population Characteristics of study participants 42.4% female N = 115 57.6% male 115 patients (48 female, 66 male) Inclusion criteria: adults patients with moderate to severe ARDS who were mechanically ventilated for < 72 hours Key exclusion criteria: ventilation for > 10 days; evidence of barotrauma; active bronchospasm or significant obstructive or restrictive pulmonary disease; any suspicion of raised ICP; unstable cardiovascular status Interventions N=58 PHARLAP intervention (maximal lung recruitment, titrated positive end expiratory pressure and further tidal volume limitation for up to the first 5 days) N=57 control (protective ventilation based on ARDS Network protocol) https://web.pathway.md/studies/rec1aKN7SfqJZ1uFr 1/2 6/29/23, 1:37 AM PHARLAP Pathway Primary outcome Ventilator-free days at day 28 16.0 days 16 14.5 12.0 days 8.0 days 4.0 days No significant difference 0.0 days PHARLAP intervention Control No significant difference in ventilator-free days at day 28 (16 days vs. 14.5 days; AD 1.5 days, 95% CI -41.26 to 44.26) Secondary outcomes No significant difference in death at day 28 (24.6% vs. 26.8%; ARD -2.2, 95% CI -17.47 to 13.07) No significant difference in length of stay in the ICU (11.1 days vs. 13.8 days; AD -2.7 days, 95% CI -15.4 to 10) No significant difference in length of hospital stay (20.1 days vs. 17.9 days; AD 2.2 days, 95% CI -13.82 to 18.22) Safety outcomes No significant differences in serious adverse events, barotrauma, pneumothorax requiring chest drain, bradycardia, severe hypotension. Significant differences in new cardiac arrhythmia (29% vs. 13%), new inhaled nitric oxide cases (10.3% vs. 28.6%), new ECMO (1.7% vs. 12.5%), new prone positioning cases (6.9% vs. 12.5%). Conclusion In adults patients with moderate to severe ARDS who were mechanically ventilated for < 72 hours, PHARLAP intervention was not superior to control with respect to a ventilator-free days at day 28. Reference Carol L Hodgson, D James Cooper, Yaseen Arabi et al. Maximal Recruitment Open Lung Ventilation in Acute Respiratory Distress Syndrome (PHARLAP). A Phase II, Multicenter Randomized Controlled Clinical Trial. Am J Respir Crit Care Med. 2019 Dec 1;200(11):1363-1372. Open reference URL https://web.pathway.md/studies/rec1aKN7SfqJZ1uFr 2/2