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Completed

NCT Number: NCT02873494

PHYSIOFLOW/Comparison of Cardiac Output Measurement

PhysioFlow® (PF®) is a new cardiac output (CO) monitoring method by impedance cardiography (IC), never studied in pediatric intensive care unit (PICU). The aim of the study was to compare CO and cardiac index (CI) measurements (IC) by trans-thoracic Doppler echocardiography (TTE) (COTTE and CITTE) and PF® (COIC and CIIC) in PICU.

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Key information

Conditions

Age range

28 day–10 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Lille University Hospital

Lille, 59037, France

About this study

In this monocentric prospective study in PICU of the CHRU of Lille, simultaneous sets of three measurements were realized by TTE and PF® in 43 patients.

In the study, the patient will receive a measure of CF by impedancemetry chest. This electrode will be glued on the torso and the neck of the child. We will collect information obtained through IT, to compare the results obtained by the ETT, carried out under the support of the child. The study will last 15 minutes maximum. No blood sampling will be conducted for the purpose of the study, apart from the exams necessary to its support and its treatment. At no time, the results of the impedance will affect support. The study will use only the data contained in the medical file of the child and would involve no additional intervention (no examination, no further treatment). The use of these data will then be anonymous. After anonymization, information recorded will computer processing of the data collected.

Concordance correlation coefficient (CCC) and Bland-Altman analysis with log-transformed data were used to compare CO, CI, stroke volume (SV) and systemic vascular resistance (SVR) measurements.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Children aged from 28 days to 10 years hospitalized in Pediatric ICU, including therapeutic support requires a hemodynamic assessment by ETT.

Exclusion criteria

  • Refusal of the child or refusal of one of the holders of parental authority
  • Cardiac rhythm disorders
  • Greater than 240 beats per minute tachycardia
  • Burns or skin lesions of thorax
  • Poor Echogenicity
  • Congenital heart disease complex (except a persistent ductus arterious and interventricular or interventricular communication)
  • Aortic insufficiency

Treatment and study plan

PHYSIOFLOW - PF05 Lab1TM

Device

Primary outcomes

  1. The concordance between DC and IC and SVR measurements obtained with both techniques, IT and the ETT in pediatric intensive care patient.

    Time frame: Within the time hemodynamic assessment by echocardiography, less than 15 minutes.

    The percentage of acceptable error between the two methods must be less than 30%, The aim of the study was to compare CO and cardiac index (CI) measurements by trans-thoracic Doppler echocardiography (TTE) (COTTE and CITTE) and PF® (COIC and CIIC) in PICU.

Secondary outcomes

  1. CO and CI measures

    Time frame: Within the time hemodynamic assessment by echocardiography, less than 15 minutes.

    The concordance of the CO and CI and SVR measures obtained by these two methods in mechanical ventilation and requiring treatments inotropic and vasoactive.

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

Impedance Cardiography by PhysioFlow® for Non-invasive Cardiac Output Monitoring: a Comparison With Trans-thoracic Echocardiography in Pediatric Intensive Care Patients.

Acronym: PF-ECHO

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Aug 19, 2016
Registry last updated
Aug 19, 2016

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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