EchocardiographyCardioLogNCT04310904
Cardiac Output Assessment by Using Saline Contrast Injection
An observational study of Echocardiography, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Echocardiography
- What is being tested?
- contrast assessment of cardiac output (CO) and cardiac Doppler technique
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 6 Mar 2019to 10 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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: all ICU patients intubated/ventilated with a central line and an arterial catheter who need trans esophageal echocardiography examination with a saline contrast test.
Who may be able to join
- all ICU patients intubated/ventilated with a central line and an arterial catheter who need trans esophageal echocardiography examination with a saline contrast test.
Who cannot join
- patients under 18 years old
- pregnant patients
- moribund patients
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Echocardiography
- Being tested
- contrast assessment of cardiac output (CO), cardiac Doppler technique
- Keywords
- echocardiography, Doppler cardiac output, contrast, thermodilution, agitated saline, ICU
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
contrast assessment of cardiac output (CO)Other
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.
cardiac Doppler techniqueOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: contrast assessment of cardiac output (CO); Other: cardiac Doppler technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
variation of cardiac output assessment (CO)
correlation will be done between contrast and the reference method cardiac Doppler method.
Measured: day 0
Secondary outcomes (1)
variation of cardiac output assessment (CO) in patients with a swan gaz catheter
comparison will be performed between the contrast CO and the thermodilution CO in the group of patients with a swan ganz catheter
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start6 Mar 2019
- Primary completionMar 2024 (estimated)
- Study completion10 Mar 2026
Why it stopped: Difficult recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EchocardiographyStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04310904
- Sponsor's protocol ID
- PI2018_843_0057
- Acronym
- CardioLog
- Status last verified
- Jun 2026
- First submitted
- 13 Mar 2020
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Output Assessment by Using Saline Contrast Injection
- ClinicalTrials.gov ID
- NCT04310904
- Acronym / sponsor ID
- CardioLog / PI2018_843_0057
- Conditions
- Echocardiography
- Keywords
- echocardiography, Doppler cardiac output, contrast, thermodilution, agitated saline, ICU
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Difficult recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 6 Mar 2019 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- 10 Mar 2026 (actual)
- First posted
- 17 Mar 2020 (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) 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU cardiac output (CO) assessment patients | – | Other: contrast assessment of cardiac output (CO), Other: cardiac Doppler techniqueall ICU patients intubated/ventilated with a central line and an arterial catheter who need trans esophageal echocardiography examination with a saline contrast test. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- all ICU patients intubated/ventilated with a central line and an arterial catheter who need trans esophageal echocardiography examination with a saline contrast test.
Key exclusion criteria (3 listed)
- patients under 18 years old
- pregnant patients
- moribund patients
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 |
|---|---|---|
| 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 | ICU cardiac output (CO) assessment patients |
| cardiac Doppler techniquePatients 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 | ICU cardiac output (CO) assessment patients |
Primary outcome
variation of cardiac output assessment (CO)
Time frame: day 0
correlation will be done between contrast and the reference method cardiac Doppler method.
1 secondary outcome
variation of cardiac output assessment (CO) in patients with a swan gaz catheter
Time frame: day 0
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Echocardiography
RecruitingPhase 3
Comparing the Safety and Efficacy of ASI-02 to Agitated Saline for Suspected Right-to-left Shunt
Right-To-Left Shunt
Not yet recruitingObservational study
Metabolic Changes in Heart Failure Patients Treated With Vericiguat
Heart Failure, Worsening Heart Failure
RecruitingObservational study
Cardiac Arrest - Ultrasound Detection of Occult Perfusion
Cardiac Arrest, Out-Of-Hospital, Hypotension
Not yet recruiting
Ultrasound Guided Leadless Pacemaker Implantation
Leadless Pacemaker, Transthoracic Echocardiography
Enrolling by invitationObservational study
Intracardiac Echocardiography Catheter Supply-Chain Reliability and Clinical Access Study
Cardiovascular Diseases, Arrhythmias, Cardiac
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Echocardiography, run by Centre Hospitalier Universitaire, Amiens 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 1 inclusion and 3 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: withdrawn, as of the sponsor's last update on 15 Jun 2026. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
variation of cardiac output assessment (CO) (time frame: day 0). 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 15 Jun 2026.