Clinical trial NCT02873494: PHYSIOFLOW/Comparison of Cardiac Output Measurement
Official title: Impedance Cardiography by PhysioFlow® for Non-invasive Cardiac Output Monitoring: a Comparison With Trans-thoracic Echocardiography in Pediatric Intensive Care Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric Disorders
Keywords: Hemodynamic monitoring
cardiac output
Transthoracic echocardiography
Impedance cardiography
Child
Physioflow
pediatric intensive care unit
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2016-08-19
Enrollment: 43
Sex: ALL
Minimum age (years): 28
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Child hospitalized in pediatric intensive care unit aged from 28 days to 10 years. Any change of treatment was performed during inclusion

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.

Eligibility criteria: 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

Primary outcomes:
measure: The concordance between DC and IC and SVR measurements obtained with both techniques, IT and the ETT in pediatric intensive care patient.
timeFrame: Within the time hemodynamic assessment by echocardiography, less than 15 minutes.
Secondary outcomes:
measure: CO and CI measures
timeFrame: Within the time hemodynamic assessment by echocardiography, less than 15 minutes.
Other outcomes:
Locations:
city: Lille
country: France
facility: Lille University Hospital
Study officials:
affiliation: Lille University Hospital
name: ASTRID BOTTE, PH
role: PRINCIPAL_INVESTIGATOR
References: