Right‑heart function and heart–lung interaction during ARDS with mechanical ventilation
Official title: Incidence and Evolution of Heart-lung Interaction in Acute Respiratory Distress Syndrome: the IVOLIA Study
Run by Bicetre Hospital · NCT07450846 · Data updated 2026-11-12
This project will follow adults with ARDS on mechanical ventilation to see how positive‑pressure breathing affects the right heart over time and how that relates to circulation.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | Bicetre Hospital Academic / other |
| Locations | 1 site (Le Kremlin-Bicêtre) |
| Status | Recruiting |
| Started | December 22, 2022 |
| Main results expected | January 2028 |
| Study ends | January 2028 |
| Registry record updated | March 5, 2026 |
| Trial ID | NCT07450846 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) in intensive care with ARDS who are mechanically ventilated and can undergo serial echocardiography at the required timepoints are ideal candidates.
✕Probably not a fit
Patients who are not mechanically ventilated, who are pregnant, or who have poor echogenicity that prevents reliable heart measurements are unlikely to benefit from participating.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an observational cohort of adult ICU patients with ARDS who are treated with mechanical ventilation and undergo serial echocardiography. Investigators will collect cardiac ultrasound, hemodynamic data, vasoactive drug use, and tissue oxygenation at predefined timepoints (first 24 hours, 48–96 hours, day 5–7, and within 48 hours of extubation). The study aims to describe the incidence and temporal evolution of right ventricular failure, identify phenotypes based on ultrasound and hemodynamic parameters, and relate these patterns to prognosis and volume status. Patients who are pregnant or have poor echocardiographic windows are excluded.
Why it matters
Potential benefit: If successful, the findings could help clinicians detect right heart dysfunction earlier and tailor ventilation and cardiovascular support to improve patient outcomes.
How similar studies have gone: Large prior studies have shown modern protective ventilation lowered the overall incidence of right ventricular failure in ARDS, but few longitudinal studies have mapped its evolution and hemodynamic consequences over time.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years old * Hospitalization in intensive care undergoing mechanical ventilation * Presence of ARDS according to the current consensus definition (Berlin definition) * Performance of at least one echocardiography during the first 24 hours of treatment, between the 2nd and 3rd day, between the 5th and 7th day, and within 48 hours of extubation Exclusion Criteria: Pregnancy Poor echogenicity preventing reliable measurement of the dimensions of the right and left ventricles.
Where it's running
-
Chu de Bicêtre, AP-HP
Le Kremlin-Bicêtre, France Recruiting
Study contacts
- Study coordinator: Xavier Monnet, MD, PhD
- Email: xavier.monnet@aphp.fr
- Phone: +33-(0)6660862669
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.