Cardiac Output MeasurementRIGHT WAYNCT07177391
Discontinuous Echocardiographic Subcostal Cardiac Output Measurement
An observational study of Cardiac Output Measurement, run by University Hospital, Rouen at 1 site in France.
Trial summary
Cardiac output (CO) monitoring is recommended for the most serious and multiple-failure patients in critical care and allows the diagnosis of acute circulatory failure as well as its etiology and also allows the monitoring of treatments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Output Measurement
- What is being tested?
- Discontinuous subcostal echocardiographic cardiac output assessment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 25 Nov 2024to 30 Oct 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is a prospective cohort including patients admitted to the intensive care unit of the Rouen University Hospital and requiring, upon admission or during their stay, the performance of a transthoracic echocardiography for diagnostic assessment and/or therapeutic monitoring.
Who may be able to join
- Adult patient (Age ≥ 18 years)
- Patient admitted to the intensive care unit at Rouen University Hospital.
- Transthoracic echocardiography (TTE) is required upon admission or during the patient's stay for diagnostic assessment and/or therapeutic monitoring.
Who cannot join
- Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection/guardianship or curatorship
- Patient not affiliated with the social security system
- Refusal by the patient or trusted person if the patient is incapable of expressing consent
- Pregnant woman
- Dying patient
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
University Rouen Hospital
Rouen, 76031
Thomas TM MAUDHUIZON, Doctor, 02 32 88 82 61 ext. +33, t.maudhuizon@gmail.com
About this study
Official title: Discontinuous Echocardiographic Subcostal Cardiac Output Measurement by the Right Ventricular Outflow Tract in Critical Care
Cardiac output (CO) monitoring is recommended for the most serious and multiple-failure patients in critical care and allows the diagnosis of acute circulatory failure as well as its etiology and also allows the monitoring of treatments. However, although allowing an adaptation of hemodynamic treatments and being integrated into a therapeutic personalization approach in situations of acute circulatory failure, the measurement of CO is conditioned by the availability of devices, by their sometimes problematic invasiveness, as well as their cost. In addition, the discontinuous measurement of CO by echocardiography is made difficult in the context of resuscitation with patients who are less mobilizable and less echogenic.
Read the detailed description
The subcostal assessment route is the classic emergency route. It allows for the analysis of the basic segmental kinetics of the left ventricle, an analysis of the Left Ventricular Ejection Fraction (LVEF), the search for pericardial effusion or even tamponade, or the search for right ventricular dilation. A measurement of CO via the right ventricular outflow tract using transthoracic echocardiography has never been described in the literature, although it is feasible, based on the same mathematical rationale as the standard measurement of cardiac output via the left ventricular outflow tract (which takes into account the diameter of the outflow tract and the subvalvular time-velocity integral [TVI]).
Since at all times the left (systemic) CO is equal to the right (venous return) CO, it is therefore possible to consider a measurement of CO via the subcostal route. By not complicating the standard care of patients in critical care, especially in situations of acute circulatory failure, and by adding only a few seconds or even minutes to an examination already recommended and routine in critical care, this evaluation approach seems interesting given the need and the recommendations in force on the monitoring of patients in intensive care and more particularly of DC.
- Conditions
- Cardiac Output Measurement
- Being tested
- Discontinuous subcostal echocardiographic cardiac output assessment
- Keywords
- diagnosis of circulatory failure, multiple failures in critical care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discontinuous subcostal echocardiographic cardiac output assessmentOther
Right Ventricular Outflow Chamber Diameter (RVOD) and Left Ventricular Outflow Chamber Diameter (LVOD) assessments via subcostal approach
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of Cardiac Output (CO) via the subcostal route
To assess the concordance of the measurement of cardiac output in the ejection chamber of the right ventricle (DC-CEVD, innovative method) with that of cardiac output in the ejection chamber of the left ventricle (DC-CEVG, reference method) on subcostal transthoracic ultrasound (TTE).
Measured: At Enrollment visit and DAY 28
Secondary outcomes (3)
Compare the measurement success rate of DC-CEVD to that of DC-CEVG.
Evaluate the success of cardiac output measurement, defined by the fact of rendering a flow measurement
Measured: At Enrollment visit and DAY 28
To assess the concordance of DC variation during preload-dependence search maneuvers (passive leg raise) in intubated and ventilated patients between DC-CEVD and DC-CEVG measurements.
Evaluation of DC Variation during the preload-dependence search maneuver: passive leg raise test and 1-minute DC measurement according to the two modalities (DC-CEVD and DC-CEVG measurements).
Measured: At Enrollment visit and DAY 28
DC measurement by transpulmonary thermodilution device
Search for the best concordance of the DC-CEVD to the Plan for Continuity of Circulation and Oxygenation (PCCO) and of the DC-CEVG to the PCCOi in a patient who has a transpulmonary thermodilution device with analysis of the pulse wave contour (PCCO), (PiCCO2),
Measured: At Enrollment visit and DAY 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start25 Nov 2024
- Primary completion9 Sep 2025
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Output MeasurementStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07177391
- Sponsor's protocol ID
- 2024/0200/OB
- Other IDs
- 2024-A01706-41
- Acronym
- RIGHT WAY
- Status last verified
- Sep 2025
- First submitted
- 9 Sep 2025
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data provided will be the property of the sponsor and will be used solely for its own research activities.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discontinuous Echocardiographic Subcostal Cardiac Output Measurement by the Right Ventricular Outflow Tract in Critical Care
- ClinicalTrials.gov ID
- NCT07177391
- Acronym / sponsor ID
- RIGHT WAY / 2024/0200/OB
- Conditions
- Cardiac Output Measurement
- Keywords
- diagnosis of circulatory failure, multiple failures in critical care
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 25 Nov 2024 (actual)
- Primary completion
- 9 Sep 2025 (actual)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 17 Sep 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.
Cardiac output (CO) monitoring is recommended for the most serious and multiple-failure patients in critical care and allows the diagnosis of acute circulatory failure as well as its etiology and also allows the monitoring of treatments. However, although allowing an adaptation of hemodynamic treatments and being integrated into a therapeutic personalization approach in situations of acute circulatory failure, the measurement of CO is conditioned by the availability of devices, by their sometimes problematic invasiveness, as well as their cost. In addition, the discontinuous measurement of CO by echocardiography is made difficult in the context of resuscitation with patients who are less mobilizable and less echogenic.
Detailed description
The subcostal assessment route is the classic emergency route. It allows for the analysis of the basic segmental kinetics of the left ventricle, an analysis of the Left Ventricular Ejection Fraction (LVEF), the search for pericardial effusion or even tamponade, or the search for right ventricular dilation. A measurement of CO via the right ventricular outflow tract using transthoracic echocardiography has never been described in the literature, although it is feasible, based on the same mathematical rationale as the standard measurement of cardiac output via the left ventricular outflow tract (which takes into account the diameter of the outflow tract and the subvalvular time-velocity integral [TVI]).
Since at all times the left (systemic) CO is equal to the right (venous return) CO, it is therefore possible to consider a measurement of CO via the subcostal route. By not complicating the standard care of patients in critical care, especially in situations of acute circulatory failure, and by adding only a few seconds or even minutes to an examination already recommended and routine in critical care, this evaluation approach seems interesting given the need and the recommendations in force on the monitoring of patients in intensive care and more particularly of DC.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a prospective cohort including patients admitted to the intensive care unit of the Rouen University Hospital and requiring, upon admission or during their stay, the performance of a transthoracic echocardiography for diagnostic assessment and/or therapeutic monitoring.
Key inclusion criteria (3 listed)
- Adult patient (Age ≥ 18 years)
- Patient admitted to the intensive care unit at Rouen University Hospital.
- Transthoracic echocardiography (TTE) is required upon admission or during the patient's stay for diagnostic assessment and/or therapeutic monitoring.
Key exclusion criteria (5 listed)
- Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection/guardianship or curatorship
- Patient not affiliated with the social security system
- Refusal by the patient or trusted person if the patient is incapable of expressing consent
- Pregnant woman
- Dying patient
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 |
|---|---|---|
| Discontinuous subcostal echocardiographic cardiac output assessmentRight Ventricular Outflow Chamber Diameter (RVOD) and Left Ventricular Outflow Chamber Diameter (LVOD) assessments via subcostal approach | Other | – |
Primary outcome
Measurement of Cardiac Output (CO) via the subcostal route
Time frame: At Enrollment visit and DAY 28
To assess the concordance of the measurement of cardiac output in the ejection chamber of the right ventricle (DC-CEVD, innovative method) with that of cardiac output in the ejection chamber of the left ventricle (DC-CEVG, reference method) on subcostal transthoracic ultrasound (TTE).
3 secondary outcomes
Compare the measurement success rate of DC-CEVD to that of DC-CEVG.
Time frame: At Enrollment visit and DAY 28
To assess the concordance of DC variation during preload-dependence search maneuvers (passive leg raise) in intubated and ventilated patients between DC-CEVD and DC-CEVG measurements.
Time frame: At Enrollment visit and DAY 28
DC measurement by transpulmonary thermodilution device
Time frame: At Enrollment visit and DAY 28
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 17 Sep 2025.
- Individual participant dataSharing planned: No. The data provided will be the property of the sponsor and will be used solely for its own research activities.
Related trials for Cardiac Output Measurement
RecruitingObservational study
Urine Output Response to Fluid and Diuretic Therapy in Cardiac ICU Patients Monitored With FIZE kUO®
AKI - Acute Kidney Injury, Cardiac Surgery
Recruiting
Assessment of Pulmonary Perfusion and Hemodynamic Measurements by Electrical Impedance Tomography in Patients Undergoing Pulmonary Thromboendarterectomy.
Pulmonary Thromboendarterectomy, Pulmonary Embolism and Thrombosis
Enrolling by invitationObservational study
CTICU Device Study CRUISE
Open Heart Surgery
Recruiting
Electrical Impedance Tomography for Assessment of Pulmonary Hypertension
Pulmonary Hypertension, Pulmonary Thromboembolisms
Enrolling by invitationObservational study
COR-INSIGHT: Optimizing Cardiovascular and Cardiopulmonary Outcomes with AI-Driven Multiplexed Indications Using COR ECG Wearable
Cardiopulmonary Failure, Myocardial Infarction (MI)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Output Measurement, run by University Hospital, Rouen at 1 site in France.
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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Contact Thomas TM MAUDHUIZON, Doctor (02 32 88 82 61 ext. +33, t.maudhuizon@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of Cardiac Output (CO) via the subcostal route (time frame: At Enrollment visit and DAY 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Sep 2025.