Left Ventricular Outflow Tract Mean Velocity in Children: a Strong Alternative to Cardiac Index in Pediatric Intensive Care Unit

February 15, 2025 updated by: GIROUX Nathan, Central Hospital, Nancy, France

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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

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

Study Locations

  • France
    • Lorraine
      • Vandoeuvre-lès-Nancy, Lorraine, France, 54500
        • CHRU of Nancy

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

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

infants, children, and adolescents hospitalized in our Pediatric Intensive Care Unit (PICU) in a non-surgical cardiology unit

Description

Inclusion Criteria:

  • infants, children, and adolescents hospitalized in our Pediatric Intensive Care Unit (PICU) in a non-surgical cardiology unit requiring hemodynamic assessment

Exclusion Criteria:

  • documented irregular heart rates (HR) or with congenital heart malformations that could affect aortic measurements or LVOT velocity (such as aortic valve anomalies)

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
correlation between LVOT mean velocity (LVOTmv) from the traditional apical five-chamber view and standard CI measurements
Time Frame: 1 day
1 day

Collaborators and Investigators

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

Sponsor

Central Hospital, Nancy, France

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)

May 1, 2020

Primary Completion (Actual)

July 1, 2022

Study Completion (Actual)

July 1, 2022

Study Registration Dates

First Submitted

February 11, 2025

First Submitted That Met QC Criteria

February 15, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 15, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025PI012

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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