Clinical Trial

HemodynamIc eFfects of Lung Collapse and overdIstension During ARDS

Study acronym: HI-FIVE
Not Yet Recruiting
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Summary
The management ARDS relies on ventilatory strategies aimed at limiting ventilator-induced lung injury (VILI). The setting of PEEP is still subject of debate, as randomized clinical trials comparing standardized higher versus lower PEEP strategies failed to demonstrate a clear survival advantage. Only few studies explored the hemodynamic effects of various PEEP levels depending on lung recruitability. Furthermore, the role of PEEP-mediated lung collapse and overdistention on patients' hemodynamics has yet to be elucidated. In this physiologic study, the association between EIT-measured lung collapse and overdistention and cardiac function will be explored, accounting for the individual potential for lung recruitment, partitioned respiratory mechanics and cardiac preload responsiveness. Three PEEP levels will be tested in a randomized, crossover fashion: PEEP corresponding to the crossing point between lung collapse and overdistention, PEEP associated with low lung collapse, PEEP associated with low lung overdistention.
Trial Details
NCT Number NCT07423520
Lead Sponsor Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions ARDS, AHRF
Enrollment 20 participants
Start Date 2026-02-28
Primary Completion 2027-02-28 (estimated)
Study Completion 2027-05-01 (estimated)
Updated on ClinicalTrials.gov 2026-02-20