Right heart strain during artificial ventilation in acute respiratory distress syndrome
Follows how the right side of the heart changes in intensive care adults.
Key facts
- Who runs it
- Bicetre Hospital
- Where
- Le Kremlin-Bicêtre, FranceSee the site
- Trial code
- Registry title
- Incidence and Evolution of Heart-lung Interaction in Acute Respiratory Distress Syndrome
- Status
- Recruiting
- People taking part
- 500 people, planned
- Started
- 22 Dec 2022
- Expected to end
- Jan 2028
- Type of study
- Observational
- Record updated
- 5 March 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults in intensive care who are on a breathing machine (mechanical ventilation) because of acute respiratory distress syndrome (ARDS).
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- ARDS as defined by the Berlin definition, in a person in intensive care on mechanical ventilation
- Earlier treatment
- Must be on mechanical ventilation in intensive care. At least one heart ultrasound (echocardiography) must have been done in one of the set time windows: first 24 hours of treatment, day 2 to 3, day 5 to 7, or within 48 hours of extubation.
Main reasons for not taking part
- Pregnancy
- Poor heart ultrasound image quality, so the size of the right and left ventricles cannot be measured reliably
The registry criteria, word for word
Show all 5 criteriaShow less
Who can take part
- 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
Who cannot take part
- Pregnancy Poor echogenicity preventing reliable measurement of the dimensions of the right and left ventricles
Where in France
- Chu de Bicêtre, AP-HPLe Kremlin-Bicêtre, FranceContact: Xavier Monnet, MD, PhDTaking people
About the trial
What the trial wants to find out
Acute respiratory distress syndrome (ARDS) is an inflammatory injury of the lungs caused by various serious illnesses, such as a bacterial or viral lung infection. It is treated by artificial ventilation with the application of positive pressure. Pulmonary injury, coupled with artificial ventilation, can lead to right heart failure which hinders the ejection of blood to the pulmonary circulation. Modern mechanical ventilation modalities have reduced the frequency ("incidence") of this right heart failure in acute respiratory distress syndrome. A large-scale study has shown this a few years ago. However, the evolution of right heart failure during artificial ventilation, and the consequences it has on the patient's cardiovascular status are poorly determined. This study is conducted to improve knowledge in this area. In adult patients hospitalized in intensive care presenting acute respiratory distress syndrome, the investigators will collect the data recorded on cardiac ultrasound, doses of cardiovascular drugs as well as variables reflecting hemodynamic status and cell oxygenation. Data will be collected during the course of ARDS and mechanical ventilation, as well as after weaning from artificial ventilation.
The group in the trial
- Patients with ARDS under mechanical ventilation
* Age ≥18 years old * Hospitalization in intensive care * Presence of ARDS according to the current consensus definition
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Incidence and Evolution of Heart-lung Interaction in Acute Respiratory Distress Syndrome: the IVOLIA Study
- Plain-language title
- Right heart strain during artificial ventilation in acute respiratory distress syndromeGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 5 March 2026