ARDS(ECHO-REVEAL)NCT06812949
Echocardiographic Right Ventricular Evaluation in Assessment of ARDS Lung Recruitment (ECHO-REVEAL)
An observational study of ARDS, run by University of Bari at 3 sites in 2 countries.
Trial summary
Study Goal The goal of this observational, multicenter study is to evaluate how positive end-expiratory pressure (PEEP) affects right ventricular (RV) function in patients with acute respiratory distress syndrome (ARDS) who are receiving mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- ARDS
- What is being tested?
- PEEP Titration with Echocardiographic, Hemodynamic, and Ventilatory Measurements
- How many people
- 60 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 2 Feb 2025to Feb 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult patients (aged 18-80 years) diagnosed with moderate-to-severe acute respiratory distress syndrome (ARDS) who are undergoing mechanical ventilation in intensive care units (ICUs) at participating medical centers. Participants will be recruited from tertiary care hospitals specializing in critical care and echocardiography, specifically from the Intensive Care Units (ICU) of the following institutions: 1. Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari, Italy - Department of Intensive Care 2. Hôpital Erasme, Université Libre de Bruxelles (ULB), Brussels, Belgium - Department of Intensive Care 3. Centre Hospitalier Universitaire (CHU) Saint-Pierre, Brussels, Belgium - Department of Intensive Care The study focuses on critically ill patients requiring invasive mechanical ventilation, where PEEP titration and recruitment maneuvers are part of standard clinical practice.
Who may be able to join
- Patients within 1 week from the diagnosis of acute respiratory distress syndrome (ARDS), defined according to the Berlin criteria.
- Non-pregnant.
- Age greater than or equal to 18 years.
- Monitored through MostCare Up or any other system for cardiac output (CO) monitoring and with invasive CVP catheter.
- Able to provide written informed consent to participate in the study directly or by a delegate.
Who cannot join
- Patients with severe pulmonary hypertension for any causes, defined by am echocardiographic PAPs ≥ 70 mmHg.
- Patients with tricuspid valve prostheses or percutaneous implanted devices (Triclip).
- Patients recently (within 1 month) undergoing cardiac surgery involving pericardiotomy.
- Patients with pre-existing severe tricuspid regurgitation.
- Patients with haemodynamic instability requiring high-dose vasopressors and/or inotropic agents in which recruitment manoeuvre are not considered to be safe according to clinical judgement.
- Patients whose acoustic window does not allow for the acquisition of the measurements under examination with transthoracic echocardiography.
- Patients with documented moderate-to-severe pulmonary embolism or known pulmonary artery stenosis.
- Patients undergoing Extracorporeal Membrane Oxygenation (ECMO).
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Belgium2 sites
Hôpital universitaire - CHU Saint-Pierre
Brussels, Brussels Capital, 1000
Hôpital Erasme - Cliniques universitaires de Bruxelles
Brussels, Brussels Capital, 1070
Italy1 site
Azienda Ospedaliero Universitaria Consorziale Policlinico
Bari, Bari, 70100
About this study
Study Goal The goal of this observational, multicenter study is to evaluate how positive end-expiratory pressure (PEEP) affects right ventricular (RV) function in patients with acute respiratory distress syndrome (ARDS) who are receiving mechanical ventilation. Researchers will assess the Recruitment-to-Inflation (R/I) ratio, a measurement used to determine whether increasing PEEP helps open the lungs or causes harmful effects on the heart and circulation.
Main Study Questions
Read more
This study aims to answer the following questions:
- How does PEEP affect right heart function in ARDS patients?
- Can the R/I ratio predict whether PEEP will have a beneficial or harmful impact on the heart?
- Which echocardiographic parameters best detect changes in right ventricular function caused by PEEP?
Who Can Participate?
Patients will be included in the study if they meet the following criteria:
- Age: 18 to 80 years.
- Condition: Diagnosed with moderate-to-severe ARDS, with a PaO₂/FiO₂ ratio <200 mmHg (an indicator of severe breathing difficulty).
- Mechanical Ventilation: Receiving invasive ventilation with at least 5 cmH₂O of PEEP and in deep sedation (fully dependent on the ventilator).
- Cardiac Monitoring: Equipped with a MostCare Up or equivalent device for continuous heart function monitoring.
- Informed Consent: Given directly by the patient or through a legal representative.
Patients will not be included in the study if they:
- Have severe pulmonary hypertension (high pressure in the lungs, ≥70 mmHg).
- Have a tricuspid valve prosthesis or other implanted cardiac devices that interfere with echocardiographic imaging.
- Have undergone recent heart surgery (within the past month).
- Have severe tricuspid valve disease that makes it difficult to assess right heart function.
- Are hemodynamically unstable, requiring high doses of medication to maintain blood pressure.
- Have poor ultrasound imaging conditions that prevent accurate heart scans.
- Have recently had a pulmonary embolism or have known blockages in the pulmonary arteries.
- Are receiving extracorporeal membrane oxygenation (ECMO) support.
Study Procedures
Participants will undergo a series of tests to measure the impact of PEEP on lung and heart function:
- Initial Airway Closure Test: Patients will be evaluated while on a low PEEP level of 5 cmH₂O for 10 minutes to confirm eligibility.
- Recruitment-to-Inflation (R/I) Ratio Assessment:
- PEEP will be adjusted between low (5 cmH₂O) and high (15 cmH₂O) levels.
- Researchers will measure changes in lung mechanics and heart function using ultrasound.
- Echocardiographic Heart Function Assessment:
- Transthoracic echocardiography (TTE) will be performed at each PEEP level to assess the right ventricle (RV) and circulation in the lungs.
- Researchers will measure RV strain, size, and blood flow to determine how the heart reacts to PEEP changes.
- Data Collection: oKey respiratory and hemodynamic parameters will be recorded, including heart strain, cardiac output, pulmonary artery pressure, and venous congestion.
Primary and Secondary Study Outcomes
- Primary Outcome: The study will evaluate how RV function changes in response to different PEEP levels, using 2D RV strain measurements as a key indicator.
- Secondary Outcomes: Researchers will assess:
- How accurately echocardiographic measurements (e.g., TAPSE, FAC, VExUS score) detect changes in RV function.
- The relationship between the VExUS score (a marker of venous congestion) and RV strain changes.
- The sensitivity and specificity of echocardiographic findings in predicting heart function shifts under different PEEP levels.
Statistical Analysis
- Researchers will compare echocardiographic heart function results at high PEEP vs. low PEEP using statistical models.
- The relationship between the R/I ratio and RV function will be analyzed using correlation tests and logistic regression.
- Receiver Operating Characteristic (ROC) analysis will be used to determine which echocardiographic parameter best detects RV dysfunction when the R/I ratio is low.
Study Size and Impact The study aims to enroll 60 patients (30 per group) to ensure that results are reliable. This sample size was calculated to detect at least a 10% change in RV strain, with a 90% probability of identifying significant effects.
Expected Benefits of the Study This study will help critical care doctors better understand how to adjust PEEP settings to balance lung recruitment and heart function in ARDS patients. By identifying the best methods to detect right heart dysfunction early, this research could lead to improved ventilation strategies and better survival outcomes for patients with severe lung injury.m
- Conditions
- ARDS
- Being tested
- PEEP Titration with Echocardiographic, Hemodynamic, and Ventilatory Measurements
- Keywords
- Right ventricle, ARDS, Acute Respiratory Syndrome, Heart-lung interaction, Right Ventricular Strain, Recruitment manouvres, Mechanical Ventilation, PEEP, critical care ultrasounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEP Titration with Echocardiographic, Hemodynamic, and Ventilatory MeasurementsDiagnostic test
Also called Recruitment Maneuvers with Cardiorespiratory Monitoring
This intervention consists of clinical recruitment maneuvers performed in mechanically ventilated patients by adjusting positive end-expiratory pressure (PEEP) at two levels: low PEEP (5 cmH₂O) and high PEEP (15 cmH₂O). Throughout these maneuvers, echocardiographic imaging, hemodynamic assessments, and ventilatory measurements are performed to evaluate the cardiorespiratory effects of PEEP adjustments. Transthoracic echocardiography (TTE) is used to assess right ventricular function, pulmonary pressures, and venous congestion, while mechanical ventilator parameters are recorded to monitor lung mechanics and compliance.
| Study group | Role | What they receive |
|---|---|---|
| High Recruitment-to-Inflation (R/I) Ratio Group | This cohort includes ARDS patients with a Recruitment-to-Inflation (R/I) ratio > 0.5, indicating high lung recruitability in response to increased PEEP. These participants undergo a structured PEEP titration protocol, where ventilatory and hemodynamic parameters are assessed at low PEEP (5 cmH₂O) and high PEEP (15 cmH₂O). The primary focus is on evaluating right ventricular function, pulmonary pressures, and systemic hemodynamics to determine if high recruitability is associated with better tolerance to PEEP without inducing RV dysfunction. Receives: Diagnostic Test: PEEP Titration with Echocardiographic, Hemodynamic, and Ventilatory Measurements | |
| Low Recruitment-to-Inflation (R/I) Ratio Group | This cohort consists of ARDS patients with a Recruitment-to-Inflation (R/I) ratio < 0.5, signifying limited lung recruitability and an increased risk of lung overdistension when PEEP is raised. These participants undergo the same PEEP titration protocol, with echocardiographic and ventilatory assessments at 5 cmH₂O and 15 cmH₂O PEEP levels. The objective is to evaluate the hemodynamic impact of higher PEEP in patients with poor lung recruitability, particularly in terms of right ventricular strain, pulmonary vascular resistance, and systemic venous congestion. Receives: Diagnostic Test: PEEP Titration with Echocardiographic, Hemodynamic, and Ventilatory Measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association Between the Recruitment-to-Inflation (R/I) Ratio and Right Ventricular Dysfunction in Mechanically Ventilated ARDS Patients
The primary outcome of this study is to determine whether an unfavorable Recruitment-to-Inflation (R/I) ratio (<0.5) is associated with right ventricular (RV) dysfunction in ARDS patients undergoing PEEP titration during mechanical ventilation. RV function will be assessed through 2D speckle-tracking echocardiography (STE) of the RV free wall longitudinal strain (RVFWS) at low PEEP (5 cmH₂O) and high PEEP (15 cmH₂O). The study hypothesizes that patients with an R/I ratio <0.5 will show a significant increase (less negative values) in RV strain at high PEEP, indicating impaired RV function due to excessive lung overdistension and increased pulmonary vascular resistance.
Measured: Within 30 minutes of PEEP titration at both high and low PEEP levels.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start2 Feb 2025
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for ARDSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of Bari
- Sponsor type
- University, hospital or other
- Collaborators
- Erasme University Hospital, Centre Hospitalier Universitaire Saint Pierre
- Responsible party
- Principal investigator, Salvatore Grasso, University of Bari
- Investigators
- Francesco Grasso, Medicine and Surgery, Study chair, University of Bari Aldo Moro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06812949
- Sponsor's protocol ID
- Prot.2026/CEL
- Acronym
- (ECHO-REVEAL)
- Status last verified
- Feb 2025
- First submitted
- 2 Feb 2025
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to ethical considerations, patient confidentiality, and data protection regulations. The study involves sensitive clinical and echocardiographic data collected from critically ill patients in intensive care units, which are subject to strict privacy and institutional policies. Additionally, the study protocol does not include provisions for external data sharing. However, aggregated and anonymized results will be made available through scientific publications and conference presentations.
Publications
Vieillard-Baron A, Schmitt JM, Augarde R, Fellahi JL, Prin S, Page B, Beauchet A, Jardin F. Acute cor pulmonale in acute respiratory distress syndrome submitted to protective ventilation: incidence, clinical implications, and prognosis. Crit Care Med. 2001 Aug;29(8):1551-5. doi: 10.1097/00003246-200108000-00009.
PubMed 11505125Zapol WM, Snider MT. Pulmonary hypertension in severe acute respiratory failure. N Engl J Med. 1977 Mar 3;296(9):476-80. doi: 10.1056/NEJM197703032960903.
PubMed 834225Vieillard-Baron A, Prin S, Chergui K, Dubourg O, Jardin F. Echo-Doppler demonstration of acute cor pulmonale at the bedside in the medical intensive care unit. Am J Respir Crit Care Med. 2002 Nov 15;166(10):1310-9. doi: 10.1164/rccm.200202-146CC. No abstract available.
PubMed 12421740Banavasi H, Nguyen P, Osman H, Soubani AO. Management of ARDS - What Works and What Does Not. Am J Med Sci. 2021 Jul;362(1):13-23. doi: 10.1016/j.amjms.2020.12.019. Epub 2020 Dec 26.
PubMed 34090669WHITTENBERGER JL, McGREGOR M, BERGLUND E, BORST HG. Influence of state of inflation of the lung on pulmonary vascular resistance. J Appl Physiol. 1960 Sep;15:878-82. doi: 10.1152/jappl.1960.15.5.878. No abstract available.
PubMed 13784949Mahmood SS, Pinsky MR. Heart-lung interactions during mechanical ventilation: the basics. Ann Transl Med. 2018 Sep;6(18):349. doi: 10.21037/atm.2018.04.29.
PubMed 30370276Price LC, McAuley DF, Marino PS, Finney SJ, Griffiths MJ, Wort SJ. Pathophysiology of pulmonary hypertension in acute lung injury. Am J Physiol Lung Cell Mol Physiol. 2012 May 1;302(9):L803-15. doi: 10.1152/ajplung.00355.2011. Epub 2012 Jan 13.
PubMed 22246001Evrard B, Goudelin M, Giraudeau B, Francois B, Vignon P. Right ventricular failure is strongly associated with mortality in patients with moderate-to-severe COVID-19-related ARDS and appears related to respiratory worsening. Intensive Care Med. 2022 Jun;48(6):765-767. doi: 10.1007/s00134-022-06730-0. Epub 2022 May 12. No abstract available.
PubMed 35552780Repesse X, Charron C, Vieillard-Baron A. Acute cor pulmonale in ARDS: rationale for protecting the right ventricle. Chest. 2015 Jan;147(1):259-265. doi: 10.1378/chest.14-0877.
PubMed 25560864
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Echocardiographic Right Ventricular Evaluation in Assessment of ARDS Lung Recruitment (ECHO-REVEAL)
- ClinicalTrials.gov ID
- NCT06812949
- Acronym / sponsor ID
- (ECHO-REVEAL) / Prot.2026/CEL
- Conditions
- ARDS
- Keywords
- Right ventricle, ARDS, Acute Respiratory Syndrome, Heart-lung interaction, Right Ventricular Strain, Recruitment manouvres, Mechanical Ventilation, PEEP
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of BariUniversity, hospital or other
- Collaborators
- Erasme University Hospital, Centre Hospitalier Universitaire Saint Pierre
- Study start
- 2 Feb 2025 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 6 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study Goal The goal of this observational, multicenter study is to evaluate how positive end-expiratory pressure (PEEP) affects right ventricular (RV) function in patients with acute respiratory distress syndrome (ARDS) who are receiving mechanical ventilation. Researchers will assess the Recruitment-to-Inflation (R/I) ratio, a measurement used to determine whether increasing PEEP helps open the lungs or causes harmful effects on the heart and circulation.
Main Study Questions
This study aims to answer the following questions:
- How does PEEP affect right heart function in ARDS patients?
- Can the R/I ratio predict whether PEEP will have a beneficial or harmful impact on the heart?
- Which echocardiographic parameters best detect changes in right ventricular function caused by PEEP?
Who Can Participate?
Patients will be included in the study if they meet the following criteria:
- Age: 18 to 80 years.
- Condition: Diagnosed with moderate-to-severe ARDS, with a PaO₂/FiO₂ ratio <200 mmHg (an indicator of severe breathing difficulty).
- Mechanical Ventilation: Receiving invasive ventilation with at least 5 cmH₂O of PEEP and in deep sedation (fully dependent on the ventilator).
- Cardiac Monitoring: Equipped with a MostCare Up or equivalent device for continuous heart function monitoring.
- Informed Consent: Given directly by the patient or through a legal representative.
Patients will not be included in the study if they:
- Have severe pulmonary hypertension (high pressure in the lungs, ≥70 mmHg).
- Have a tricuspid valve prosthesis or other implanted cardiac devices that interfere with echocardiographic imaging.
- Have undergone recent heart surgery (within the past month).
- Have severe tricuspid valve disease that makes it difficult to assess right heart function.
- Are hemodynamically unstable, requiring high doses of medication to maintain blood pressure.
- Have poor ultrasound imaging conditions that prevent accurate heart scans.
- Have recently had a pulmonary embolism or have known blockages in the pulmonary arteries.
- Are receiving extracorporeal membrane oxygenation (ECMO) support.
Study Procedures
Participants will undergo a series of tests to measure the impact of PEEP on lung and heart function:
- Initial Airway Closure Test: Patients will be evaluated while on a low PEEP level of 5 cmH₂O for 10 minutes to confirm eligibility.
- Recruitment-to-Inflation (R/I) Ratio Assessment:
- PEEP will be adjusted between low (5 cmH₂O) and high (15 cmH₂O) levels.
- Researchers will measure changes in lung mechanics and heart function using ultrasound.
- Echocardiographic Heart Function Assessment:
- Transthoracic echocardiography (TTE) will be performed at each PEEP level to assess the right ventricle (RV) and circulation in the lungs.
- Researchers will measure RV strain, size, and blood flow to determine how the heart reacts to PEEP changes.
- Data Collection: oKey respiratory and hemodynamic parameters will be recorded, including heart strain, cardiac output, pulmonary artery pressure, and venous congestion.
Primary and Secondary Study Outcomes
- Primary Outcome: The study will evaluate how RV function changes in response to different PEEP levels, using 2D RV strain measurements as a key indicator.
- Secondary Outcomes: Researchers will assess:
- How accurately echocardiographic measurements (e.g., TAPSE, FAC, VExUS score) detect changes in RV function.
- The relationship between the VExUS score (a marker of venous congestion) and RV strain changes.
- The sensitivity and specificity of echocardiographic findings in predicting heart function shifts under different PEEP levels.
Statistical Analysis
- Researchers will compare echocardiographic heart function results at high PEEP vs. low PEEP using statistical models.
- The relationship between the R/I ratio and RV function will be analyzed using correlation tests and logistic regression.
- Receiver Operating Characteristic (ROC) analysis will be used to determine which echocardiographic parameter best detects RV dysfunction when the R/I ratio is low.
Study Size and Impact The study aims to enroll 60 patients (30 per group) to ensure that results are reliable. This sample size was calculated to detect at least a 10% change in RV strain, with a 90% probability of identifying significant effects.
Expected Benefits of the Study This study will help critical care doctors better understand how to adjust PEEP settings to balance lung recruitment and heart function in ARDS patients. By identifying the best methods to detect right heart dysfunction early, this research could lead to improved ventilation strategies and better survival outcomes for patients with severe lung injury.m
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Recruitment-to-Inflation (R/I) Ratio Group | – | Diagnostic Test: PEEP Titration with Echocardiographic, Hemodynamic, and Ventilatory MeasurementsThis cohort includes ARDS patients with a Recruitment-to-Inflation (R/I) ratio > 0.5, indicating high lung recruitability in response to increased PEEP. These participants undergo a structured PEEP titration protocol, where ventilatory and hemodynamic parameters are assessed at low PEEP (5 cmH₂O) and high PEEP (15 cmH₂O). The primary focus is on evaluating right ventricular function, pulmonary pressures, and systemic hemodynamics to determine if high recruitability is associated with better tolerance to PEEP without inducing RV dysfunction. |
| Low Recruitment-to-Inflation (R/I) Ratio Group | – | Diagnostic Test: PEEP Titration with Echocardiographic, Hemodynamic, and Ventilatory MeasurementsThis cohort consists of ARDS patients with a Recruitment-to-Inflation (R/I) ratio < 0.5, signifying limited lung recruitability and an increased risk of lung overdistension when PEEP is raised. These participants undergo the same PEEP titration protocol, with echocardiographic and ventilatory assessments at 5 cmH₂O and 15 cmH₂O PEEP levels. The objective is to evaluate the hemodynamic impact of higher PEEP in patients with poor lung recruitability, particularly in terms of right ventricular strain, pulmonary vascular resistance, and systemic venous congestion. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients (aged 18-80 years) diagnosed with moderate-to-severe acute respiratory distress syndrome (ARDS) who are undergoing mechanical ventilation in intensive care units (ICUs) at participating medical centers. Participants will be recruited from tertiary care hospitals specializing in critical care and echocardiography, specifically from the Intensive Care Units (ICU) of the following institutions: 1. Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari, Italy - Department of Intensive Care 2. Hôpital Erasme, Université Libre de Bruxelles (ULB), Brussels, Belgium - Department of Intensive Care 3. Centre Hospitalier Universitaire (CHU) Saint-Pierre, Brussels, Belgium - Department of Intensive Care The study focuses on critically ill patients requiring invasive mechanical ventilation, where PEEP titration and recruitment maneuvers are part of standard clinical practice.
Key inclusion criteria (5 listed)
- Patients within 1 week from the diagnosis of acute respiratory distress syndrome (ARDS), defined according to the Berlin criteria.
- Non-pregnant.
- Age greater than or equal to 18 years.
- Monitored through MostCare Up or any other system for cardiac output (CO) monitoring and with invasive CVP catheter.
- Able to provide written informed consent to participate in the study directly or by a delegate.
Key exclusion criteria (8 listed)
- Patients with severe pulmonary hypertension for any causes, defined by am echocardiographic PAPs ≥ 70 mmHg.
- Patients with tricuspid valve prostheses or percutaneous implanted devices (Triclip).
- Patients recently (within 1 month) undergoing cardiac surgery involving pericardiotomy.
- Patients with pre-existing severe tricuspid regurgitation.
- Patients with haemodynamic instability requiring high-dose vasopressors and/or inotropic agents in which recruitment manoeuvre are not considered to be safe according to clinical judgement.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEEP Titration with Echocardiographic, Hemodynamic, and Ventilatory MeasurementsAlso: Recruitment Maneuvers with Cardiorespiratory MonitoringThis intervention consists of clinical recruitment maneuvers performed in mechanically ventilated patients by adjusting positive end-expiratory pressure (PEEP) at two levels: low PEEP (5 cmH₂O) and high PEEP (15 cmH₂O). Throughout these maneuvers, echocardiographic imaging, hemodynamic assessments, and ventilatory measurements are performed to evaluate the cardiorespiratory effects of PEEP adjustments. Transthoracic echocardiography (TTE) is used to assess right ventricular function, pulmonary pressures, and venous congestion, while mechanical ventilator parameters are recorded to monitor lung mechanics and compliance. | Diagnostic test | High Recruitment-to-Inflation (R/I) Ratio Group, Low Recruitment-to-Inflation (R/I) Ratio Group |
Primary outcome
Association Between the Recruitment-to-Inflation (R/I) Ratio and Right Ventricular Dysfunction in Mechanically Ventilated ARDS Patients
Time frame: Within 30 minutes of PEEP titration at both high and low PEEP levels.
The primary outcome of this study is to determine whether an unfavorable Recruitment-to-Inflation (R/I) ratio (<0.5) is associated with right ventricular (RV) dysfunction in ARDS patients undergoing PEEP titration during mechanical ventilation. RV function will be assessed through 2D speckle-tracking echocardiography (STE) of the RV free wall longitudinal strain (RVFWS) at low PEEP (5 cmH₂O) and high PEEP (15 cmH₂O). The study hypothesizes that patients with an R/I ratio <0.5 will show a significant increase (less negative values) in RV strain at high PEEP, indicating impaired RV function due to excessive lung overdistension and increased pulmonary vascular resistance.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Background: PubMed 11505125Vieillard-Baron A, Schmitt JM, Augarde R, Fellahi JL, Prin S, Page B, Beauchet A, Jardin F. Acute cor pulmonale in acute respiratory distress syndrome submitted to protective ventilation: incidence, clinical implications, and prognosis. Crit Care Med. 2001 Aug;29(8):1551-5. doi: 10.1097/00003246-200108000-00009.
- Background: PubMed 834225Zapol WM, Snider MT. Pulmonary hypertension in severe acute respiratory failure. N Engl J Med. 1977 Mar 3;296(9):476-80. doi: 10.1056/NEJM197703032960903.
- Background: PubMed 12421740Vieillard-Baron A, Prin S, Chergui K, Dubourg O, Jardin F. Echo-Doppler demonstration of acute cor pulmonale at the bedside in the medical intensive care unit. Am J Respir Crit Care Med. 2002 Nov 15;166(10):1310-9. doi: 10.1164/rccm.200202-146CC. No abstract available.
- Background: PubMed 34090669Banavasi H, Nguyen P, Osman H, Soubani AO. Management of ARDS - What Works and What Does Not. Am J Med Sci. 2021 Jul;362(1):13-23. doi: 10.1016/j.amjms.2020.12.019. Epub 2020 Dec 26.
- Background: PubMed 13784949WHITTENBERGER JL, McGREGOR M, BERGLUND E, BORST HG. Influence of state of inflation of the lung on pulmonary vascular resistance. J Appl Physiol. 1960 Sep;15:878-82. doi: 10.1152/jappl.1960.15.5.878. No abstract available.
- Background: PubMed 30370276Mahmood SS, Pinsky MR. Heart-lung interactions during mechanical ventilation: the basics. Ann Transl Med. 2018 Sep;6(18):349. doi: 10.21037/atm.2018.04.29.
- Background: PubMed 22246001Price LC, McAuley DF, Marino PS, Finney SJ, Griffiths MJ, Wort SJ. Pathophysiology of pulmonary hypertension in acute lung injury. Am J Physiol Lung Cell Mol Physiol. 2012 May 1;302(9):L803-15. doi: 10.1152/ajplung.00355.2011. Epub 2012 Jan 13.
- Background: PubMed 35552780Evrard B, Goudelin M, Giraudeau B, Francois B, Vignon P. Right ventricular failure is strongly associated with mortality in patients with moderate-to-severe COVID-19-related ARDS and appears related to respiratory worsening. Intensive Care Med. 2022 Jun;48(6):765-767. doi: 10.1007/s00134-022-06730-0. Epub 2022 May 12. No abstract available.
- Background: PubMed 25560864Repesse X, Charron C, Vieillard-Baron A. Acute cor pulmonale in ARDS: rationale for protecting the right ventricle. Chest. 2015 Jan;147(1):259-265. doi: 10.1378/chest.14-0877.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to ethical considerations, patient confidentiality, and data protection regulations. The study involves sensitive clinical and echocardiographic data collected from critically ill patients in intensive care units, which are subject to strict privacy and institutional policies. Additionally, the study protocol does not include provisions for external data sharing. However, aggregated and anonymized results will be made available through scientific publications and conference presentations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesco Grasso, Medicine and Surgery study chair
University of Bari Aldo Moro
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ARDS, run by University of Bari at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association Between the Recruitment-to-Inflation (R/I) Ratio and Right Ventricular Dysfunction in Mechanically Ventilated ARDS Patients (time frame: Within 30 minutes of PEEP titration at both high and low PEEP levels.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06812949, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2025.