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NCT07423520: HI-FIVE
HemodynamIc eFfects of Lung Collapse and overdIstension During ARDS
NA trial testing Change in PEEP in ARDS in 20 participants. Not yet recruiting.
28 February 2027
Quick facts
| Lead sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 20 |
| Start date | 28 February 2026 |
| Primary completion | 28 February 2027 |
| Estimated completion | 1 May 2027 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Change in PEEP
Conditions studied
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Who can join
18 and older, any sex, with ARDS or AHRF. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07423520
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for ARDS
Currently open trials in the same condition.
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- NCT07298889 — High PEEP in Noninvasive Ventilation Patients With Pneumonia or ARDS · NA · recruiting
- NCT07193719 — Influence of Personalized Lung Volume Optimization Maneuver on Lung Function and Cardiac Performance in Children · Phase 1, PHASE2 · recruiting
- NCT07370610 — Electrical Impedance Tomography-Based Dynamic Ventilation-Perfusion Functional Phenotype Trajectory in Acute Respiratory · active not recruiting
- NCT06647784 — Lateral Positioning and Prone Positioning in ARDS Patients · NA · recruiting
Other Fondazione Policlinico Universitario Agostino Gemelli IRCCS trials
Trials by the same sponsor.
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- NCT07520643 — MISTIC Study: Atherosclerosis, Neurocognition & Cardiovascular Signaling · not yet recruiting
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- NCT07494227 — Development of the SC-IBD Self-Care Measurement Scale · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07423520 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Last refreshed: 20 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07423520.
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