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Completed

NCT Number: NCT06837727

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

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.

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Key information

Conditions

Shock Circulatory Cardiogenic Shock Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Shock, Cardiogenic Vascular Diseases

Age range

0 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU of Nancy

Vandœuvre-lès-Nancy, Lorraine, 54500, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. correlation between LVOT mean velocity (LVOTmv) from the traditional apical five-chamber view and standard CI measurements

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 20, 2025
Registry last updated
Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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