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Clinical Trials in Italy / NCT07423520
Starting soon Not applicable

HemodynamIc eFfects of Lung Collapse and overdIstension During ARDS

NCT07423520 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2026-02-28
Last updated
2026-02-20

Condition(s) studied

ARDSAHRF

Investigational drug(s) / intervention(s)

Change in PEEP

Change in PEEP: Patients will undergo a decremental PEEP trial to determine the crossing-point PEEP. Secondly, three PEEP levels (low collapse PEEP, low overdistention PEEP and crossing point between lung collapse and overdistention PEEP) will be compared in a randomized order with 30-minute steps

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * acute respiratory failure with onset \< 1 week from a predisposing risk factor, such as pneumonia, non-pulmonary infection, trauma, transfusion, aspiration, or shock; * bilateral opacities on chest radiography and computed tomography or bilateral B lines and/or consolidations on lung ultrasound not fully explained by effusions, atelectasis, or nodules/masses; * pulmonary edema not exclusively or primarily attributable to cardiogenic pulmonary edema/fluid overload, and hypoxemia/gas exchange abnormalities not primarily attributable to atelectasis; * PaO2/FiO2 ratio ≤ 200 during invasive controlled mechanical ventilation; Exclusion Criteria: * age \<18 years; * pregnancy; * signs of barotrauma or documented pneumothorax; * severe tachycardia (HR \> 120 bpm) and severe lacticaemia (lac \> 4 mmol/L) * pre-existing decompensated heart failure (NYHA class 3-4 and/or documented left ventricular ejection fraction \< 35%); * contraindications to EIT placing (open chest wounds, presence of cardiac pacemaker); * intubation as a result of an acute exacerbation of chronic pulmonary disease; * contraindications to esophageal balloon placement (high bleeding risk, esophageal varices).

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Fondazione Policlinico Universitario A.Gemelli IRCCS Rome Rome

More Fondazione Policlinico Universitario Agostino Gemelli IRCCS trials in Italy

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07423520 on ClinicalTrials.gov ↗ ← All trials in Italy