Incidence and Evolution of Heart-lung Interaction in Acute Respiratory Distress Syndrome (IVOLIA)

Incidence and Evolution of Heart-lung Interaction in Acute Respiratory Distress Syndrome: the IVOLIA Study

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Respiratory Distress Syndrome; Right Heart Failure

Detailed Description

During acute respiratory distress syndrome (ARDS), lung damage, coupled with positive pressure artificial ventilation, can lead to failure of the right ventricle by modifying its loading conditions. The "protective" modalities used today to ventilate these patients have reduced the incidence of this right heart failure in ARDS. However, the evolution of right heart failure during mechanical ventilation, and its consequence on the hemodynamic state of the patient are poorly determined. The aim of this study is to improve knowledge in this area.The main objective of the current project is to describe the incidence of right heart failure in patients with ARDS placed on artificial ventilation and its evolution over time. The secondary objectives are to describe the simultaneous evolution of the hemodynamic state, the use of cardiovascular drugs and the variables of tissue oxygenation, to describe the phenotypes of patients presenting with right heart failure during ARDS in function of ultrasound, hemodynamic and tissue oxygenation characteristics, to describe the association of these different phenotypes with the prognosis, to describe the risk factors for these different phenotypes and to describe the influence on right heart failure during ARDS on factors related to the patient's volume status.

In adult patients hospitalized in intensive care presenting with ARDS, the investigators will collect data recorded during the first 24 hours, after 48-96 hours, on day 5-7 and within 48 hours after extubation. The investigators will collect ventilatory and hemodynamic data, data provided by cardiac ultrasound, vasopressor and inotropic drug doses and tissue oxygenation variables.

This is an observational multicenter study, in which the investigators plan to include 500 patients over a total period of 24 months.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Xavier Monnet, MD, PhD; Phone Number: +33-(0)6660862669; Email: xavier.monnet@aphp.fr
• Study Contact Backup: Name: Christopher Lai, MD, PhD; Phone Number: +33145212671; Email: christopher.lai@aphp.fr

Study Locations

• France
  • Le Kremlin-Bicêtre, France, 94270
    • Recruiting
    • Chu de Bicêtre, AP-HP
    • Contact: Xavier Monnet, MD, PhD; Phone Number: +33680821557; Email: xavier.monnet@aphp.fr
    • Contact: Christopher Lai, MD, PhD; Phone Number: 0145212671; Email: christopher.lai@aphp.fr
    • Sub-Investigator: Christopher Lai, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

• Hospitalization in intensive care
• Age ≥18 years
• Patients under mechanical ventilation
• Presence of acute respiratory distress syndrome according to the Berlin definition

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with ARDS under mechanical ventilation; Age ≥18 years old; Hospitalization in intensive care; Presence of ARDS according to the current consensus definition

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and evolution of right heart failure during ARDS	Interpretation of echocardiography during the first 24 hours of treatment, between the 2nd and 3rd day, between the 5th and 7th day and after extubation.	From enrollment to the end of the treatment at 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The temporal evolution of the haemodynamic status	Describe the temporal evolution of hemodynamic status, assessed by changes in cardiovascular medication use (type and dose of vasopressors and inotropes, including norepinephrine µg/kg/min or vasopressin U/min) and tissue oxygenation variables from blood samples (including lactate mmol/l and ScvO2, %) on the same days as the echocardiography.	From enrollment to the end of treatment at 8 weeks
Phenotypic description of patients affected by right heart failure during ARDS	Identification and description of different phenotypes of RV failure in ARDS based on data from ultrasound, haemodynamic and tissue oxygenation characteristics the same day of echocardiography	From enrollment to the end of treatment at 8 weeks
Association of these different phenotypes with the prognosis		From enrollment to the end of the treatment at 8 weeks
Describe the risk factors for the occurrence of different phenotypes of right heart failure during ARDS	To describe the risk factors for the ocurrence of different phenotypes of right heart failure during ARDS, based on hemodynamic status including systemic and pulmonary arterial pressure (mmHg), medication use (type and dose of vasopressors and inotropes, including norepinephrine µg/kg/min or vasopressin U/min) and tissue oxygenation variables from blood samples (including lactate mmol/l and ScvO2, %), as well as echocardiographic assessment.	From enrollment to the end of treatment at 8 weeks
Effects of right ventricular failure on tests and indices of preload dependence using mechanical ventilation	Tests of preload dependence used in clinical praxis and ultrasound characteristics the same day of echocardiography	From enrollment to the end of treatment at 8 weeks
Describe the effect of norepinephrine and/or vasopressin on the pulmonary circulation	In patients with treatment of norepinephrine or vasopressin the effect on the pulmonary circulation will be studied with hemodynamic monitoring such as echocardiography and pulmonary artery catheter according to clinical care.	From enrollment to the end of treatment at 8 weeks

Collaborators and Investigators

• Sponsor: Bicetre Hospital
• Collaborators: Hôpital Cochin; Henri Mondor University Hospital; Tenon Hospital, Paris; Humanitas Hospital, Italy

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2022
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: December 16, 2022
• First Submitted That Met QC Criteria: February 26, 2026
• First Posted (Actual): March 5, 2026

Study Record Updates

• Last Update Posted (Actual): March 5, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: mechanical ventilation; ARDS; shock; heart-lung interactions
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Pathological Conditions, Signs and Symptoms; Heart Failure; Respiratory Distress Syndrome; Shock
• Other Study ID Numbers: 22-068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No