NCT07177391

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 25, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 9, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 17, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2025

Completed
Last Updated

September 17, 2025

Status Verified

September 1, 2025

Enrollment Period

10 months

First QC Date

September 9, 2025

Last Update Submit

September 9, 2025

Conditions

Keywords

diagnosis of circulatory failuremultiple failures in critical care

Outcome Measures

Primary Outcomes (1)

  • 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).

    At Enrollment visit and DAY 28

Secondary Outcomes (3)

  • Compare the measurement success rate of DC-CEVD to that of DC-CEVG.

    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.

    At Enrollment visit and DAY 28

  • DC measurement by transpulmonary thermodilution device

    At Enrollment visit and DAY 28

Interventions

Right Ventricular Outflow Chamber Diameter (RVOD) and Left Ventricular Outflow Chamber Diameter (LVOD) assessments via subcostal approach

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Rouen Hospital

Rouen, 76031, France

RECRUITING

Central Study Contacts

Thomas TM MAUDHUIZON, Doctor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2025

First Posted

September 17, 2025

Study Start

November 25, 2024

Primary Completion

September 9, 2025

Study Completion

October 30, 2025

Last Updated

September 17, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

The data provided will be the property of the sponsor and will be used solely for its own research activities.

Locations