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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-A0132835 | Other Identifier | ID-RCB number, ANSM |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PHYSIOFLOW PF05 Lab1TM | Impedance cardiography |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PHYSIOFLOW - PF05 Lab1TM | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Child hospitalized in pediatric intensive care unit aged from 28 days to 10 years. Any change of treatment was performed during inclusion
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| Name | Affiliation | Role |
|---|---|---|
| ASTRID BOTTE, PH | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lille University Hospital | Lille | 59037 | France |
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