Breathing Machine Pressure and Vein Congestion in Acute Respiratory Distress Syndrome
Observes how breathing machine pressure affects vein congestion in adults with acute respiratory distress syndrome.
Key facts
- Who runs it
- University Hospital, Angers
- Where
- Angers, FranceSee the site
- Trial code
- Registry title
- Relationship Between the Level of Positive End-expiratory Pressure and Venous Congestion During Acute Respiratory Distress Syndrome.
- Status
- Not yet recruiting
- People taking part
- 30 people, planned
- Started
- 1 Mar 2026
- Expected to end
- 1 Nov 2027
- Type of study
- Observational
- Treatments tested
- Non-interventionnal study
- Record updated
- 5 March 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults in intensive care who are on a breathing machine and have acute respiratory distress syndrome (ARDS). It checks how the machine's pressure setting affects vein congestion on ultrasound.
- Age
- 18 to 99 years
- Sex
- Women and men can join.
- Disease stage
- Acute respiratory distress syndrome (ARDS): low blood oxygen (PaO₂/FiO₂ ratio below 300 mmHg with PEEP of 5 cmH₂O or more), lung fluid not fully explained by heart failure or fluid overload, and opacities on both lungs on chest imaging.
- Earlier treatment
- Must be on a breathing machine in assist-control mode in the Medical Intensive Care and Hyperbaric Medicine Unit of Angers University Hospital.
Main reasons for not taking part
- On ECMO (extracorporeal membrane oxygenation)
- Unstable blood pressure (mean arterial pressure below 60 mmHg) or unstable breathing (SpO₂ below 90% with FiO₂ above 90%)
- Severe organic tricuspid regurgitation, congenital heart disease or pneumothorax
- Kidney or liver transplant, cirrhosis Child-Pugh C, portal vein thrombosis or Budd-Chiari syndrome
- Pregnant, breastfeeding or peripartum women
The registry criteria, word for word
Show all 19 criteriaShow less
Who can take part
- 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
Who cannot take part
- Renal or hepatic transplant recipient
- Congenital heart disease
- Portal vein thrombosis or Budd-Chiari syndrom
- Abdominal compartment syndrome documented by intra-abdominal pressure ≥20 mmHg
- Persons subject to compulsory psychiatric care
- 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
- Pneumothorax
- Liver cirrhosis Child-Pugh C
- Pregnant, breastfeeding, or peripartum women
- Persons deprived of liberty by judicial or administrative decision
- Persons under legal protective measures
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 99 years old?
Where in France
- University hospital of AngersAngers, FranceContact: Pierre ASFARNo longer taking part
About the trial
What the trial wants to find out
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.
The group in the trial
- ARDS (Acute respiratory distress syndrome)
Patient with ARDS who are placed on mechanical ventilation
Treatment: Non-interventionnal study
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Relationship Between the Level of Positive End-expiratory Pressure and Venous Congestion During Acute Respiratory Distress Syndrome.
- Plain-language title
- Breathing Machine Pressure and Vein Congestion in Acute Respiratory Distress SyndromeGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Fit questions
- Built from NCT07452952, who can take part
- Record updated
- 5 March 2026