PHYSIOFLOW/Comparison of Cardiac Output Measurement

Pediatric Disorders Clinical Trial

— PF-ECHO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02873494
• Other study ID #: 2012_25
• Secondary ID: 2012-A0132835
• Status: Completed
• Phase: N/A
• First received: September 16, 2014
• Last updated: August 16, 2016
• Start date: February 2013
• Est. completion date: February 2016

Study information

• Verified date: August 2016
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 10 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pediatric Disorders

Intervention

Device:
• PHYSIOFLOW - PF05 Lab1TM

Locations

Country	Name	City	State
France	Lille University Hospital	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The concordance between DC and IC and SVR measurements obtained with both techniques, IT and the ETT in pediatric intensive care patient.	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.	Within the time hemodynamic assessment by echocardiography, less than 15 minutes.	No
Secondary	CO and CI measures	The concordance of the CO and CI and SVR measures obtained by these two methods in mechanical ventilation and requiring treatments inotropic and vasoactive.	Within the time hemodynamic assessment by echocardiography, less than 15 minutes.	No