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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorUniversity Hospital, Angers

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Minor patient (<18 years old)

ECMO (Extracorporeal Membrane Oxygenation)

Hemodynamic instability (mean arterial pressure <60 mmHg)

Respiratory instability (SpO₂ <90% under FiO₂ >90%)

Trial 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

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • Non-interventionnal study

    Other intervention

    Non-interventionnal study

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: ARDS (Acute respiratory distress syndrome)1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

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