Shock CirculatoryNCT06837727
Left Ventricular Outflow Tract Mean Velocity in Children: a Strong Alternative to Cardiac Index in Pediatric Intensive Care Unit
An observational study of Shock Circulatory and Cardiogenic Shock, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Objectives: Noninvasive assessment of cardiac index (CI) in pediatric critical ill patient is crucial. Aortic Velocity Time Integral (VTI) valuable in adults, faces age and heart rate variability challenges in pediatrics, complicating CI interpretation in shocked patients. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Shock Circulatory, Cardiogenic Shock
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2020to 1 Jul 2022
- 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 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: infants, children, and adolescents hospitalized in our Pediatric Intensive Care Unit (PICU) in a non-surgical cardiology unit
Who may be able to join
- infants, children, and adolescents hospitalized in our Pediatric Intensive Care Unit (PICU) in a non-surgical cardiology unit requiring hemodynamic assessment
Who cannot join
- documented irregular heart rates (HR) or with congenital heart malformations that could affect aortic measurements or LVOT velocity (such as aortic valve anomalies)
Trial locations and contacts
1 site in 1 country.
About this study
Objectives: Noninvasive assessment of cardiac index (CI) in pediatric critical ill patient is crucial. Aortic Velocity Time Integral (VTI) valuable in adults, faces age and heart rate variability challenges in pediatrics, complicating CI interpretation in shocked patients. Measurement errors can complicate CI evaluation, particularly in shocked patients. Considering the proportional relationship between aortic annulus and Body Surface Area (BSA) in children, along with the relatively constant mean aortic velocity, we studied if Left Ventricular Outflow Tract mean-velocity (LVOTmv) reliably estimates bedside CI.
Design : retrospective, observational, single-center study.
Read more
Setting : Pediatric Intensive Care Unit (PICU) in a tertiary care hospital.
Patients : one hundred forty-four children in PICU (age 0-17 years, BSA 0.11-1.69 m2) requiring hemodynamic evaluation.
Intervention : Bedside ultrasound by expert cardiologists
Measurements and Main Results : We explored the correlation between LVOTmv (measured in pulse wave doppler from the apical five-chamber view) and standard CI estimation (multiplying aortic VTI, heart rate, and aortic valve area). We excluded arrhythmia and anomalies of the left ventricular outflow tract.
- Conditions
- Shock Circulatory, Cardiogenic Shock
- Keywords
- Cardiac Index, hemodynamic, echocardiography, intensive care unit
- Medical subject headings
- Shock, Shock, Cardiogenic
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation between LVOT mean velocity (LVOTmv) from the traditional apical five-chamber view and standard CI measurements
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start1 May 2020
- Primary completion1 Jul 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shock CirculatoryStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GIROUX Nathan, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06837727
- Sponsor's protocol ID
- 2025PI012
- Status last verified
- Feb 2025
- First submitted
- 11 Feb 2025
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Ventricular Outflow Tract Mean Velocity in Children: a Strong Alternative to Cardiac Index in Pediatric Intensive Care Unit
- ClinicalTrials.gov ID
- NCT06837727
- Acronym / sponsor ID
- 2025PI012
- Conditions
- Shock Circulatory, Cardiogenic Shock
- Keywords
- Cardiac Index, hemodynamic, echocardiography, intensive care unit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 20 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.
Objectives: Noninvasive assessment of cardiac index (CI) in pediatric critical ill patient is crucial. Aortic Velocity Time Integral (VTI) valuable in adults, faces age and heart rate variability challenges in pediatrics, complicating CI interpretation in shocked patients. Measurement errors can complicate CI evaluation, particularly in shocked patients. Considering the proportional relationship between aortic annulus and Body Surface Area (BSA) in children, along with the relatively constant mean aortic velocity, we studied if Left Ventricular Outflow Tract mean-velocity (LVOTmv) reliably estimates bedside CI.
Design : retrospective, observational, single-center study.
Setting : Pediatric Intensive Care Unit (PICU) in a tertiary care hospital.
Patients : one hundred forty-four children in PICU (age 0-17 years, BSA 0.11-1.69 m2) requiring hemodynamic evaluation.
Intervention : Bedside ultrasound by expert cardiologists
Measurements and Main Results : We explored the correlation between LVOTmv (measured in pulse wave doppler from the apical five-chamber view) and standard CI estimation (multiplying aortic VTI, heart rate, and aortic valve area). We excluded arrhythmia and anomalies of the left ventricular outflow tract.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- infants, children, and adolescents hospitalized in our Pediatric Intensive Care Unit (PICU) in a non-surgical cardiology unit
Key inclusion criteria (1 listed)
- infants, children, and adolescents hospitalized in our Pediatric Intensive Care Unit (PICU) in a non-surgical cardiology unit requiring hemodynamic assessment
Key exclusion criteria (1 listed)
- documented irregular heart rates (HR) or with congenital heart malformations that could affect aortic measurements or LVOT velocity (such as aortic valve anomalies)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
correlation between LVOT mean velocity (LVOTmv) from the traditional apical five-chamber view and standard CI measurements
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
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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.
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 Shock Circulatory and Cardiogenic Shock, run by Central Hospital, Nancy, France 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 1 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: finished, as of the sponsor's last update on 20 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
correlation between LVOT mean velocity (LVOTmv) from the traditional apical five-chamber view and standard CI measurements (time frame: 1 day). 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 20 Feb 2025.