NCT06837727

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

February 11, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 20, 2025

Completed
Last Updated

February 20, 2025

Status Verified

February 1, 2025

Enrollment Period

2.2 years

First QC Date

February 11, 2025

Last Update Submit

February 15, 2025

Conditions

Keywords

Cardiac Indexhemodynamicechocardiographyintensive care unit

Outcome Measures

Primary Outcomes (1)

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

    1 day

Eligibility Criteria

Age0 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU of Nancy

Vandœuvre-lès-Nancy, Lorraine, 54500, France

Location

MeSH Terms

Conditions

ShockShock, Cardiogenic

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsMyocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaNecrosis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Hospital Practitioner, Senior Physician

Study Record Dates

First Submitted

February 11, 2025

First Posted

February 20, 2025

Study Start

May 1, 2020

Primary Completion

July 1, 2022

Study Completion

July 1, 2022

Last Updated

February 20, 2025

Record last verified: 2025-02

Locations