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Not yet recruitingNCT07452952SURVEXUpdated Mar 5, 2026

Relationship Between the Level of Positive End-expiratory Pressure and Venous Congestion During Acute Respiratory Distress Syndrome.

An observational study in Mechanical Ventilation and Acute Respiratory Distress Syndrome (ARDS), sponsored by University Hospital, Angers. Not yet recruiting at 1 site in France. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-03-05.

Sponsored by University Hospital, Angers · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
30
Ages
18 Years to 99 Years
Sex
All
01

Study 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 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 :

  1. 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.

  2. 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.

  3. Collection of renal function with:

    • Serum creatinine and urea
    • Creatininuria on urine ionogram
    • 24-hour diuresis
  4. Collection of weight and input-output balance
  5. 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)
02

Conditions studied

  • Mechanical Ventilation
  • Acute Respiratory Distress Syndrome (ARDS)

Keywords

  • ARDS
  • venous congestion
  • VEXUS
  • PEP
  • right heart failure
  • acute cor pulmonale
03

In context

Respiratory Distress Syndrome

1,387 studies on the registry are indexed under Respiratory Distress Syndrome; 283 are open to participants now.

This study's planned enrollment of 30 is below the median of 100 across 475 observational studies indexed under Respiratory Distress Syndrome.

Browse Respiratory Distress Syndrome studies →

Lead sponsor

University Hospital, Angers is the lead sponsor of 478 studies on the registry; 120 are open to participants now.

Browse University Hospital, Angers studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
30 participants (estimated)
Patient registry
No

Groups and cohorts

  • ARDS (Acute respiratory distress syndrome)

    Patient with ARDS who are placed on mechanical ventilation

    Other: Non-interventionnal study

Interventions

  • OtherNon-interventionnal study

    Non-interventionnal study

06

What researchers measure

Primary outcomes

  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)

    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.

    Time frame: Baseline

Secondary outcomes

  1. 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)

    Time frame: From Baseline to day 8

  2. 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

  3. 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

  4. 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

    Time frame: From baseline to day 28

  5. 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

    Time frame: From baseline to Day 28

  6. 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.

    Time frame: from day 3 to day 5

  7. 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.

    Time frame: From Day 6 to Day 8

  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)

    Time frame: From baseline to day 8

07

Study locations

1 site
08

References and documents

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 20693377 ↗
  • Bellani 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 26903337 ↗
  • Grasselli 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 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Mar 2026; primary completion for Nov 2027, 20 months later.

Of 225 non-industry observational studies under Respiratory Distress Syndrome, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's planned 20 months is below that.

Counting every sponsor, half of 231 studies reached it within 24 months; a quarter within 12 and three quarters within 49.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 23, 2026
First posted
Mar 5, 2026
StartEst.
Mar 1, 2026
Primary completionEst.
Nov 1, 2027
CompletionEst.
Nov 1, 2027
Last update
Mar 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07452952
Lead sponsor
University Hospital, Angers
Responsible party
Sponsor
First posted
Mar 5, 2026
Start date
Mar 1, 2026 (estimated)
Primary completion
Nov 1, 2027 (estimated)
Completion
Nov 1, 2027 (estimated)
Last update
Mar 5, 2026

Study contacts

Pierre ASFAR
Contact
pierre.asfar@chu-angers.fr
241353637 ext. +33
Pierre ASFAR
Contact
pierre.asfar@chu-angers.fr
Pierre ASFAR
study chair · University Hospital of Angers

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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