HemodynamIc eFfects of Lung Collapse and overdIstension During ARDS (NCT07423520) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
HemodynamIc eFfects of Lung Collapse and overdIstension During ARDS
Italy20 participantsStarted 2026-02-28
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is focused on studying how lung collapse and overdistension affect the heart during ARDS — can you explain what those two problems are and whether either of them might be relevant to my current condition?
2Since this trial isn't recruiting yet, how long might it be before it actually opens, and are there other studies or treatment options I should be considering in the meantime?
3The trial seems to be measuring things like cardiac output and pulmonary vascular resistance — does that mean it involves extra monitoring procedures beyond standard ARDS care, and if so, what would those involve for me?
4This study doesn't appear to be testing a new drug or therapy but rather observing how the lungs affect the heart — does that mean participation wouldn't change how I'm treated, and what would be the potential benefit to me personally versus contributing to research?
5Given that this trial has no listed phase, which suggests it may be more of an observational or physiological study, how would my doctor decide whether joining this kind of study makes sense compared to focusing entirely on standard treatment for my ARDS?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Impact of lung collapse on cardiac output
Timeframe: Assesment performed at the end of each of the three 30 minute steps
2
Impact of lung collapse on pulmonary vascular resistance
Timeframe: Assesment performed at the end of each of the three 30 minute steps
3
Impact of lung overdistention on cardiac output
Timeframe: Assesment performed at the end of each of the three 30 minute steps
4
Impact of lung overdistention on pulmonary vascular resistance
Timeframe: Assesment performed at the end of each of the three 30 minute steps