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

August 16, 2016 updated by: University Hospital, Lille

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

43

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France, 59037
        • Lille University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 weeks to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PHYSIOFLOW PF05 Lab1TM
Impedance cardiography
Device: PHYSIOFLOW - PF05 Lab1TM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: Within the time hemodynamic assessment by echocardiography, less than 15 minutes.
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CO and CI measures
Time Frame: Within the time hemodynamic assessment by echocardiography, less than 15 minutes.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Investigators

  • Principal Investigator: ASTRID BOTTE, PH, Lille University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

September 16, 2014

First Submitted That Met QC Criteria

August 16, 2016

First Posted (Estimate)

August 19, 2016

Study Record Updates

Last Update Posted (Estimate)

August 19, 2016

Last Update Submitted That Met QC Criteria

August 16, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2012_25
  • 2012-A0132835 (Other Identifier: ID-RCB number, ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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