Mechanical VentilationSURVEXNCT07452952
Relationship Between the Level of Positive End-expiratory Pressure and Venous Congestion During Acute Respiratory Distress Syndrome.
An observational study of Mechanical Ventilation and Acute Respiratory Distress Syndrome (ARDS), run by University Hospital, Angers at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Mechanical Ventilation, Acute Respiratory Distress Syndrome (ARDS)
- What is being tested?
- Non-interventionnal study
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2026to 1 Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All 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
Who may be able to join
- 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 join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pierre ASFAR contact
France1 site
University Hospital of Angers
Angers
Pierre ASFAR, 241353637 ext. +33, pierre.asfar@chu-angers.fr
About this study
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.
Read the detailed description
All analyzes will be carried out with collection intention. All information required by the protocol is obtained from the clinical file of the Intensive care and Hyperbaric Medicine department of Angers University Hospital. This research is not involving humans on prospective data from care. This research does not require any specific investigation and does not involve no changes to support.
Clinical and biological data to be collected at inclusion (D1) :
- Demographic data: age, sex, weight (on the day of admission to intensive care and day of inclusion), medical history.
- Cause of ARDS.
- Ventilatory parameters: PEEP set by the clinician, total PEEP, Pplat, tidal volume, inspiratory and expiratory esophageal pressure if available as part of the treatment.
- Hemodynamic parameters: systolic, diastolic, mean aretrial blood pressure ; central venous pressure (if available as part of routine care); heart rate; transpulmonary thermodilution monitor data (if available as part of the routine care) or Swan-ganz catheter (if available as part of the routine care), vasoactive treatments (type and dosage).
Assessments to be carried out as part of routine care on D1, between D3 and D5 and between D6 and D8 :
- Measures relating to the mechanics of the respiratory system:
- Measurement of airway opening pressure (AOP).
- Calculation of the R/I ratio (recruitability index)
- The two PEEP levels, high and low, chosen by the clinician for performing the following measurements.
- At the two PEEP levels, the investigator will retrospectively collect the following clinical, biological, and echographic measurements, which were prospectively recorded by the clinician.
- Cardiac ultrasound:
- Right ventricular function parameters (TAPSE, S' wave, Vmax IT, diameter VD).
- Cardiac output.
- LVEF (once only)
- Evaluation of venous congestion by Doppler of the veins :
- Venous congestion is initially assessed by studying each flow individually. Doppler (suprahepatic veins, renal interlobar veins and portal vein) and graded in "absent", "moderate" or "severe" as follows :
- Suprahepatic veins: S wave > D = absent (normal) ; S wave < D = moderate ; Positive S wave = severe
- Renal interlobar veins: Continuous flow = absent (normal) ; Biphasic flow = moderate ; Monophasic flow = severe
- Portal vein: Pulsatility index < 30% = absent (normal) ; Pulsatility index ≥ 30% and ≤ 50% = moderate ; Pulsatility index > 50% = severe NB : calculation of the portal trunk pulsatility index ([(Vmax - Vmin) / Vmax], average of 3 measurements) Then the VExUS score, integrating these three signals as well as the study of the diameter of the inferior vena cavan by ultrasound, is calculated as follows:
- Grade 0 "absence of congestion": VCi < 20mm;
- Grade 1 "mild congestion": VCi ≥ 20 mm and suprahepatic venous Doppler, portal and renal normal or with signs of moderate congestion;
- Grade 2 "moderate congestion": VCi ≥ 20 mm and presence one venous flow (suprahepatic, portal, or renal) showing evidence of severe congestion;
- Grade 3 "severe congestion": VCi ≥ 20 mm and presence of several flows vein showing signs of severe congestion.
- Arterial and central venous gasometry (ScVO 2, PaCO2, PvCO2, lactate, PaO2, pH).
- Collection of hemodynamic parameters: systolic blood pressure, mean, diastolic, heart rate, central venous pressure.
- In patients with a pulmonary artery catheter: data collection following: systolic, diastolic and average PAP, cardiac index
- Collection of ventilatory parameters: plateau pressure, total PEEP, and, if available, end-inspiratory and end-expiratory esophageal pressures.
- Collection of renal function with:
- Serum creatinine and urea
- Creatininuria on urine ionogram
- 24-hour diuresis
- Collection of weight and input-output balance
- The echocardiographic data collected at inclusion and during follow-up will be processed a posteriori by two different observers.
End of monitoring data (D28):
During this visit, the following elements will be collected:
- Occurrence of acute renal failure (according to KDIGO criteria) on day 8.
- Use or not of extra-renal purification
- Survival at D28 (to characterize the population)
- Being tested
- Non-interventionnal study
- Keywords
- ARDS, venous congestion, VEXUS, PEP, right heart failure, acute cor pulmonale
- Medical subject headings
- Respiratory Distress Syndrome, Hyperemia, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-interventionnal studyOther
Non-interventionnal study
| Study group | Role | What they receive |
|---|---|---|
| ARDS (Acute respiratory distress syndrome) | Patient with ARDS who are placed on mechanical ventilation Receives: Other: Non-interventionnal study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
The evolution of venous congestion between two PEEP levels (high and low), assessed by analyzing each Doppler flow individually (hepatic veins, renal interlobar veins, and portal vein) and grading them as 'absent,' 'moderate,' or 'severe,' as well as by the VExUS score, graded from 0 to 3.
Measured: Baseline
Secondary outcomes (8)
In patients with a pulmonary artery catheter: evolution between venous congestion in abdominal venous flow and the VExUS score with right heart pressures (systolic, diastolic and mean pulmonary arterial pressure at D1, D3-D5 and D6-D8)
Measurement of pulmonary pressures (PAPs, PAPm, PAPd, PAPO) via Swan-Ganz catheters at each PEEP level (high and low)
Measured: From Baseline to day 8
Evaluate the evolution of venous congestion (VExUS score) according to the PEEP level over time (D1, D3-D5 and D6-D8) for each patient individually
Measured: From baseline to Day 8
Evaluate the evolution of venous congestion in abdominal venous flows and the VExUS score according to PEEP level
Measured: From baseline to Day 8
Incidence of acute renal failure at day 28 in patients with markers of significant venous congestion
Vexus score greater than or equal to 2 and/or change in portal flow, renal venous flow, or suprahepatic venous flow
Measured: From baseline to day 28
Incidence of renal replacement therapy on day 28 in patients with markers of significant venous congestion
Description: score greater than or equal to 2 and/or change in portal flow, renal venous flow, or suprahepatic venous flow
Measured: From baseline to Day 28
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)
The evolution of venous congestion between two PEEP levels (high and low), assessed by analyzing each Doppler flow individually (hepatic veins, renal interlobar veins, and portal vein) and grading them as 'absent,' 'moderate,' or 'severe,' as well as by the VExUS score, graded from 0 to 3.
Measured: from day 3 to day 5
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)
The evolution of venous congestion between two PEEP levels (high and low), assessed by analyzing each Doppler flow individually (hepatic veins, renal interlobar veins, and portal vein) and grading them as 'absent,' 'moderate,' or 'severe,' as well as by the VExUS score, graded from 0 to 3.
Measured: From Day 6 to Day 8
Evolution between venous congestion in abdominal venous flow and the VExUS score and echocardiographic markers of right heart function (D1, D3-D5 and D6-D8)
Measurement of TAPSE (Tricuspid annular plane systolic excursion), tricuspid S' wave, peak tricuspid regurgitation velocity at each PEEP level (high and low)
Measured: From baseline to day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Pierre ASFAR, Study chair, University Hospital of Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07452952
- Sponsor's protocol ID
- 49RC26_0031
- Acronym
- SURVEX
- Status last verified
- Jan 2026
- First submitted
- 23 Jan 2026
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Li G, Malinchoc M, Cartin-Ceba R, Venkata CV, Kor DJ, Peters SG, Hubmayr RD, Gajic O. Eight-year trend of acute respiratory distress syndrome: a population-based study in Olmsted County, Minnesota. Am J Respir Crit Care Med. 2011 Jan 1;183(1):59-66. doi: 10.1164/rccm.201003-0436OC. Epub 2010 Aug 6.
PubMed 20693377Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291.
PubMed 26903337Grasselli G, Calfee CS, Camporota L, Poole D, Amato MBP, Antonelli M, Arabi YM, Baroncelli F, Beitler JR, Bellani G, Bellingan G, Blackwood B, Bos LDJ, Brochard L, Brodie D, Burns KEA, Combes A, D'Arrigo S, De Backer D, Demoule A, Einav S, Fan E, Ferguson ND, Frat JP, Gattinoni L, Guerin C, Herridge MS, Hodgson C, Hough CL, Jaber S, Juffermans NP, Karagiannidis C, Kesecioglu J, Kwizera A, Laffey JG, Mancebo J, Matthay MA, McAuley DF, Mercat A, Meyer NJ, Moss M, Munshi L, Myatra SN, Ng Gong M, Papazian L, Patel BK, Pellegrini M, Perner A, Pesenti A, Piquilloud L, Qiu H, Ranieri MV, Riviello E, Slutsky AS, Stapleton RD, Summers C, Thompson TB, Valente Barbas CS, Villar J, Ware LB, Weiss B, Zampieri FG, Azoulay E, Cecconi M; European Society of Intensive Care Medicine Taskforce on ARDS. ESICM guidelines on acute respiratory distress syndrome: definition, phenotyping and respiratory support strategies. Intensive Care Med. 2023 Jul;49(7):727-759. doi: 10.1007/s00134-023-07050-7. Epub 2023 Jun 16.
PubMed 37326646
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between the Level of Positive End-expiratory Pressure and Venous Congestion During Acute Respiratory Distress Syndrome.
- ClinicalTrials.gov ID
- NCT07452952
- Acronym / sponsor ID
- SURVEX / 49RC26_0031
- Keywords
- ARDS, venous congestion, VEXUS, PEP, right heart failure, acute cor pulmonale
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 5 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
All analyzes will be carried out with collection intention. All information required by the protocol is obtained from the clinical file of the Intensive care and Hyperbaric Medicine department of Angers University Hospital. This research is not involving humans on prospective data from care. This research does not require any specific investigation and does not involve no changes to support.
Clinical and biological data to be collected at inclusion (D1) :
- Demographic data: age, sex, weight (on the day of admission to intensive care and day of inclusion), medical history.
- Cause of ARDS.
- Ventilatory parameters: PEEP set by the clinician, total PEEP, Pplat, tidal volume, inspiratory and expiratory esophageal pressure if available as part of the treatment.
- Hemodynamic parameters: systolic, diastolic, mean aretrial blood pressure ; central venous pressure (if available as part of routine care); heart rate; transpulmonary thermodilution monitor data (if available as part of the routine care) or Swan-ganz catheter (if available as part of the routine care), vasoactive treatments (type and dosage).
Assessments to be carried out as part of routine care on D1, between D3 and D5 and between D6 and D8 :
- Measures relating to the mechanics of the respiratory system:
- Measurement of airway opening pressure (AOP).
- Calculation of the R/I ratio (recruitability index)
- The two PEEP levels, high and low, chosen by the clinician for performing the following measurements.
- At the two PEEP levels, the investigator will retrospectively collect the following clinical, biological, and echographic measurements, which were prospectively recorded by the clinician.
- Cardiac ultrasound:
- Right ventricular function parameters (TAPSE, S' wave, Vmax IT, diameter VD).
- Cardiac output.
- LVEF (once only)
- Evaluation of venous congestion by Doppler of the veins :
- Venous congestion is initially assessed by studying each flow individually. Doppler (suprahepatic veins, renal interlobar veins and portal vein) and graded in "absent", "moderate" or "severe" as follows :
- Suprahepatic veins: S wave > D = absent (normal) ; S wave < D = moderate ; Positive S wave = severe
- Renal interlobar veins: Continuous flow = absent (normal) ; Biphasic flow = moderate ; Monophasic flow = severe
- Portal vein: Pulsatility index < 30% = absent (normal) ; Pulsatility index ≥ 30% and ≤ 50% = moderate ; Pulsatility index > 50% = severe NB : calculation of the portal trunk pulsatility index ([(Vmax - Vmin) / Vmax], average of 3 measurements) Then the VExUS score, integrating these three signals as well as the study of the diameter of the inferior vena cavan by ultrasound, is calculated as follows:
- Grade 0 "absence of congestion": VCi < 20mm;
- Grade 1 "mild congestion": VCi ≥ 20 mm and suprahepatic venous Doppler, portal and renal normal or with signs of moderate congestion;
- Grade 2 "moderate congestion": VCi ≥ 20 mm and presence one venous flow (suprahepatic, portal, or renal) showing evidence of severe congestion;
- Grade 3 "severe congestion": VCi ≥ 20 mm and presence of several flows vein showing signs of severe congestion.
- Arterial and central venous gasometry (ScVO 2, PaCO2, PvCO2, lactate, PaO2, pH).
- Collection of hemodynamic parameters: systolic blood pressure, mean, diastolic, heart rate, central venous pressure.
- In patients with a pulmonary artery catheter: data collection following: systolic, diastolic and average PAP, cardiac index
- Collection of ventilatory parameters: plateau pressure, total PEEP, and, if available, end-inspiratory and end-expiratory esophageal pressures.
- Collection of renal function with:
- Serum creatinine and urea
- Creatininuria on urine ionogram
- 24-hour diuresis
- Collection of weight and input-output balance
- The echocardiographic data collected at inclusion and during follow-up will be processed a posteriori by two different observers.
End of monitoring data (D28):
During this visit, the following elements will be collected:
- Occurrence of acute renal failure (according to KDIGO criteria) on day 8.
- Use or not of extra-renal purification
- Survival at D28 (to characterize the population)
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ARDS (Acute respiratory distress syndrome) | – | Other: Non-interventionnal studyPatient with ARDS who are placed on mechanical ventilation |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-interventionnal studyNon-interventionnal study | Other | ARDS (Acute respiratory distress syndrome) |
Primary outcome
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)
Time frame: Baseline
The evolution of venous congestion between two PEEP levels (high and low), assessed by analyzing each Doppler flow individually (hepatic veins, renal interlobar veins, and portal vein) and grading them as 'absent,' 'moderate,' or 'severe,' as well as by the VExUS score, graded from 0 to 3.
8 secondary outcomes
In patients with a pulmonary artery catheter: evolution between venous congestion in abdominal venous flow and the VExUS score with right heart pressures (systolic, diastolic and mean pulmonary arterial pressure at D1, D3-D5 and D6-D8)
Time frame: From Baseline to day 8
Evaluate the evolution of venous congestion (VExUS score) according to the PEEP level over time (D1, D3-D5 and D6-D8) for each patient individually
Time frame: From baseline to Day 8
Evaluate the evolution of venous congestion in abdominal venous flows and the VExUS score according to PEEP level
Time frame: From baseline to Day 8
Incidence of acute renal failure at day 28 in patients with markers of significant venous congestion
Time frame: From baseline to day 28
Incidence of renal replacement therapy on day 28 in patients with markers of significant venous congestion
Time frame: From baseline to Day 28
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)
Time frame: from day 3 to day 5
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)
Time frame: From Day 6 to Day 8
Evolution between venous congestion in abdominal venous flow and the VExUS score and echocardiographic markers of right heart function (D1, D3-D5 and D6-D8)
Time frame: From baseline to day 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Background: PubMed 20693377Li G, Malinchoc M, Cartin-Ceba R, Venkata CV, Kor DJ, Peters SG, Hubmayr RD, Gajic O. Eight-year trend of acute respiratory distress syndrome: a population-based study in Olmsted County, Minnesota. Am J Respir Crit Care Med. 2011 Jan 1;183(1):59-66. doi: 10.1164/rccm.201003-0436OC. Epub 2010 Aug 6.
- Background: PubMed 26903337Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291.
- Background: PubMed 37326646Grasselli G, Calfee CS, Camporota L, Poole D, Amato MBP, Antonelli M, Arabi YM, Baroncelli F, Beitler JR, Bellani G, Bellingan G, Blackwood B, Bos LDJ, Brochard L, Brodie D, Burns KEA, Combes A, D'Arrigo S, De Backer D, Demoule A, Einav S, Fan E, Ferguson ND, Frat JP, Gattinoni L, Guerin C, Herridge MS, Hodgson C, Hough CL, Jaber S, Juffermans NP, Karagiannidis C, Kesecioglu J, Kwizera A, Laffey JG, Mancebo J, Matthay MA, McAuley DF, Mercat A, Meyer NJ, Moss M, Munshi L, Myatra SN, Ng Gong M, Papazian L, Patel BK, Pellegrini M, Perner A, Pesenti A, Piquilloud L, Qiu H, Ranieri MV, Riviello E, Slutsky AS, Stapleton RD, Summers C, Thompson TB, Valente Barbas CS, Villar J, Ware LB, Weiss B, Zampieri FG, Azoulay E, Cecconi M; European Society of Intensive Care Medicine Taskforce on ARDS. ESICM guidelines on acute respiratory distress syndrome: definition, phenotyping and respiratory support strategies. Intensive Care Med. 2023 Jul;49(7):727-759. doi: 10.1007/s00134-023-07050-7. Epub 2023 Jun 16.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pierre ASFAR contact
Pierre ASFAR study chair
University Hospital of Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanical Ventilation and Acute Respiratory Distress Syndrome (ARDS), run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pierre ASFAR (241353637 ext. +33, pierre.asfar@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07452952, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.