Actively Recruiting
Incidence and Evolution of Heart-lung Interaction in Acute Respiratory Distress Syndrome: the IVOLIA Study
Led by Bicetre Hospital · Updated on 2026-03-05
500
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
B
Bicetre Hospital
Lead Sponsor
T
Tenon Hospital, Paris
Collaborating Sponsor
AI-Summary
What this Trial Is About
Acute respiratory distress syndrome (ARDS) is a serious lung condition caused by infections or other illnesses, which requires treatment with artificial ventilation using positive pressure. This condition can lead to right heart failure due to lung damage and the effects of mechanical ventilation. Researchers are studying how right heart failure develops during ARDS and how it affects the patient's heart and blood circulation, as this is not well understood. This observational study involves adult patients with ARDS who are hospitalized in intensive care and on mechanical ventilation. Data will be collected through cardiac ultrasound, monitoring of cardiovascular drug doses, and measurements of blood flow and oxygen levels in tissues. Data collection will occur during the first 24 hours, after 48 to 96 hours, on days 5 to 7, and within 48 hours after extubation. Participants will undergo several evaluations including heart ultrasounds and monitoring of hemodynamic status throughout their treatment and after ventilation ends. Researchers will analyze the incidence and changes of right heart failure, heart function, drug use, and oxygen delivery during the study period, which lasts up to eight weeks. This study aims to better understand the heart-lung interaction in ARDS and improve future care.
CONDITIONS
Brief Title
Incidence and Evolution of Heart-lung Interaction in Acute Respiratory Distress Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Hospitalization in intensive care undergoing mechanical ventilation
- Presence of ARDS according to the current consensus definition (Berlin definition)
- At least one echocardiography performed during the first 24 hours, between days 2 and 3, between days 5 and 7, and within 48 hours after extubation
You will not qualify if you...
- Pregnancy
- Poor echogenicity preventing reliable measurement of the dimensions of the right and left ventricles
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - From enrollment to 8 weeks
Participants undergo echocardiography and data collection during mechanical ventilation to assess heart-lung interactions in ARDS.
1 echocardiography within first 24 hours, 1 between days 2 and 3, 1 between days 5 and 7, and 1 within 48 hours after extubation
Duration - Up to 8 weeks
Participants are observed to track the evolution of right heart failure and hemodynamic status over time.
Trial Site Locations
Total: 1 location
1
Chu de Bicêtre, AP-HP
Le Kremlin-Bicêtre, France, 94270
Actively Recruiting
Research Team
X
Xavier Monnet, MD, PhD
C
Christopher Lai, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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