PHYSIOFLOW/Comparison of Cardiac Output Measurement (PF-ECHO)

University Hospital, Lille

Status: Completed

Conditions: Pediatric Disorders

Treatments: Device: PHYSIOFLOW - PF05 Lab1TM

Study type: Observational

Funder types: Other

Identifiers

NCT02873494

2012_25

2012-A0132835 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 43 patients

Sex: All

Ages: 28 days to 10 years old

Volunteers: No Healthy Volunteers

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

Trial design

43 participants in 1 patient group

PHYSIOFLOW PF05 Lab1TM

Description:

Impedance cardiography

Treatment:

Device: PHYSIOFLOW - PF05 Lab1TM