HemodynamIc eFfects of Lung Collapse and overdIstension During ARDS

Starting soon · Not applicable

Conditions studied: ARDS, AHRF

In brief

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.

Key facts

Study ID

NCT07423520

Run by

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

People needed

20

Starts

2026-02-28

Expected to finish

2027-05-01

Last updated by the study team

2026-02-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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;

You may not qualify if…

• 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).

Where it is running

• Fondazione Policlinico Universitario A.Gemelli IRCCS — Rome, Rome, Italy

Full record on ClinicalTrials.gov

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