PHYSIOFLOW/Comparison of Cardiac Output Measurement

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

43 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-02-28

Study Completion Date

2016-02-29

Brief Summary

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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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Detailed Description

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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.

Conditions

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Pediatric Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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PHYSIOFLOW PF05 Lab1TM

Impedance cardiography

PHYSIOFLOW - PF05 Lab1TM

Intervention Type DEVICE

Interventions

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PHYSIOFLOW - PF05 Lab1TM

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

28 Days

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No