Relationship Between the Level of Positive End-expiratory Pressure and Venous Congestion During Acute Respiratory Distress Syndrome.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- 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)
Study Overview
Brief 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.
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:
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 (SpO₂ <90% under FiO₂ >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
Arms & Interventions
ARDS (Acute respiratory distress syndrome)
Patient with ARDS who are placed on mechanical ventilation
Intervention: Non-interventionnal study (Other)
Outcomes
Primary Outcomes
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.
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)(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(From baseline to Day 8)
- Evaluate the evolution of venous congestion in abdominal venous flows and the VExUS score according to PEEP level(From baseline to Day 8)
- Incidence of acute renal failure at day 28 in patients with markers of significant venous congestion(From baseline to day 28)
- Incidence of renal replacement therapy on day 28 in patients with markers of significant venous congestion(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)(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)(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)(From baseline to day 8)