PHYSIOFLOW/Comparison of Cardiac Output Measurement

Completed

• Conditions: Pediatric Disorders
• Interventions: Device: PHYSIOFLOW - PF05 Lab1TM

• Registration Number: NCT02873494
• Lead Sponsor: University Hospital, Lille

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2014-09-16
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-08
• Study First Submitted QC: 2016-08-16
• Last Update Submitted: 2016-08-16
• Study First Posted: 2016-08-19
• Last Update Posted: 2016-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PHYSIOFLOW PF05 Lab1TM	PHYSIOFLOW - PF05 Lab1TM	Impedance cardiography

Primary Outcome Measures

Name	Time	Method
The concordance between DC and IC and SVR measurements obtained with both techniques, IT and the ETT in pediatric intensive care patient.	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 Outcome Measures

Name	Time	Method
CO and CI measures	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.

Trial Locations

Locations (1)

Lille University Hospital; 🇫🇷 Lille, France