Relationship Between the Level of Positive End-expiratory Pressure and Venous Congestion During A… (NCT07452952) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Relationship Between the Level of Positive End-expiratory Pressure and Venous Congestion During Acute Respiratory Distress Syndrome.
France30 participantsStarted 2026-03-01
Plain-language summary
The main objective is to assess the effect of increased PEEP on echo-Doppler venous congestion in ARDS patients at two PEEP levels, by grading congestion in each venous flow (suprahepatic, renal, portal) as "absent," "moderate," or "severe," and also calculating the VExUS score.
Who can participate
Age range
18 Years – 99 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:
* Patients hospitalized in the Medical Intensive Care and Hyperbaric Medicine Unit of Angers University Hospital, receiving mechanical ventilation in assist-control mode (A/C ventilation), and presenting with ARDS as defined by the following criteria (1):
* Hypoxemia with a PaO₂ (mmHg)/FiO₂ (0.21 to 1.0) ratio \<300 mmHg with a positive end-expiratory pressure (PEEP) ≥5 cmH₂O;
* Pulmonary edema not fully explained by cardiac failure or fluid overload;
* Presence of bilateral pulmonary opacities on chest imaging not fully explained by pleural effusions, atelectasis, or pulmonary nodules.
Exclusion Criteria:
* Minor patient (\<18 years old)
* ECMO (Extracorporeal Membrane Oxygenation)
* Hemodynamic instability (mean arterial pressure \<60 mmHg)
* Respiratory instability (SpO₂ \<90% under FiO₂ \>90%)
* Severe organic tricuspid regurgitation
* Congenital heart disease
* Pneumothorax
* Renal or hepatic transplant recipient
* Liver cirrhosis Child-Pugh C
* Portal vein thrombosis or Budd-Chiari syndrom
* Abdominal compartment syndrome documented by intra-abdominal pressure ≥20 mmHg
* Pregnant, breastfeeding, or peripartum women
* Persons deprived of liberty by judicial or administrative decision
* Persons subject to compulsory psychiatric care
* Persons under legal protective measures
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
Evolution of the level of venous congestion evaluated on the different abdominal Doppler venous flows (portal, suprahepatic and renal venous Doppler) and on the VExUS score between the different levels of PEEP (high and low)