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 range18 Years – 99 Years
SexALL
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 (SpOâ‚‚ \<90% under FiOâ‚‚ \>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
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)