Cardiac Output Assessment by Using Saline Contrast Injection (CardioLog)

June 12, 2026 updated by: Centre Hospitalier Universitaire, Amiens
Cardiac output (CO) assessment is one of the cornerstone of hemodynamic evaluation in ICU patients. CO is usually measured using invasive methods or non-invasive methods. Thermodilution is considered as the gold standard for CO assessment. Cardiac Doppler as well demonstrated to be accurate but needs manipulations and good knowledge and skills. The investigators developed a new technique using injection of agitated saline solution to evaluate CO without any manual measurement and then observer independent.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The investigators decided to conduct a prospective observational study to compare contrast assessment of CO and cardiac Doppler technique. Patients hospitalized in ICU will be included if they need a trans esophageal echocardiographic evaluation and a research of intra cardiac shunt (using a saline contrast test). Patients with Swan Ganz catheter will be included as well. Cardiac output will be measured using cardiac Doppler. Simultaneously, 4.5 ml of saline with 0.5 ml of air will be agitated to have a contrast solution. This solution will be injected as usual and echocardiographic imaging will be recorded. These imaging will be analyzed off-line and CO will be calculated with an algorithm previously developed and compared with the reference method. In case of swan ganz catheter, the cardiac output will be also measured using the thermodilution technique.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Amiens, France, 80480
        • CHU Amiens

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

all ICU patients intubated/ventilated with a central line and an arterial catheter who need trans esophageal echocardiography examination with a saline contrast test.

Description

Inclusion Criteria:

  • all ICU patients intubated/ventilated with a central line and an arterial catheter who need trans esophageal echocardiography examination with a saline contrast test.

Exclusion Criteria:

  • patients under 18 years old
  • pregnant patients
  • moribund patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ICU cardiac output (CO) assessment patients
all ICU patients intubated/ventilated with a central line and an arterial catheter who need trans esophageal echocardiography examination with a saline contrast test.
Other: contrast assessment of cardiac output (CO)
Patients hospitalized in ICU will be included if they need a trans esophageal echocardiographic evaluation and a research of intra cardiac shunt (using a saline contrast test). Patients with Swan Ganz catheter will be included as well. Cardiac output will be measured using cardiac Doppler. Simultaneously, 4.5 ml of saline with 0.5 ml of air will be agitated to have a contrast solution. This solution will be injected as usual and echocardiographic imaging will be recorded. These imaging will be analyzed off-line and CO will be calculated with an algorithm previously developed and compared with the reference method. In case of swan ganz catheter, the cardiac output will be also measured using the thermodilution technique.
Other: cardiac Doppler technique
Patients hospitalized in ICU will be included if they need a trans esophageal echocardiographic evaluation and a research of intra cardiac shunt (using a saline contrast test). Patients with Swan Ganz catheter will be included as well. Cardiac output will be measured using cardiac Doppler. Simultaneously, 4.5 ml of saline with 0.5 ml of air will be agitated to have a contrast solution. This solution will be injected as usual and echocardiographic imaging will be recorded. These imaging will be analyzed off-line and CO will be calculated with an algorithm previously developed and compared with the reference method. In case of swan ganz catheter, the cardiac output will be also measured using the thermodilution technique.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
variation of cardiac output assessment (CO)
Time Frame: day 0
correlation will be done between contrast and the reference method cardiac Doppler method.
day 0

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
variation of cardiac output assessment (CO) in patients with a swan gaz catheter
Time Frame: day 0
comparison will be performed between the contrast CO and the thermodilution CO in the group of patients with a swan ganz catheter
day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire, Amiens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 6, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 10, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 13, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 17, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PI2018_843_0057

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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