PHYSIOFLOW/Comparison of Cardiac Output Measurement
PF-ECHO
Impedance Cardiography by PhysioFlow® for Non-invasive Cardiac Output Monitoring: a Comparison With Trans-thoracic Echocardiography in Pediatric Intensive Care Patients.
2 other identifiers
observational
43
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2013
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 16, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedFirst Posted
Study publicly available on registry
August 19, 2016
CompletedAugust 19, 2016
August 1, 2016
3 years
September 16, 2014
August 16, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Secondary Outcomes (1)
CO and CI measures
Within the time hemodynamic assessment by echocardiography, less than 15 minutes.
Study Arms (1)
PHYSIOFLOW PF05 Lab1TM
Impedance cardiography
Interventions
Eligibility Criteria
Child hospitalized in pediatric intensive care unit aged from 28 days to 10 years. Any change of treatment was performed during inclusion
You may qualify if:
- Children aged from 28 days to 10 years hospitalized in Pediatric ICU, including therapeutic support requires a hemodynamic assessment by ETT.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lille University Hospital
Lille, 59037, France
Study Officials
- PRINCIPAL INVESTIGATOR
ASTRID BOTTE, PH
Lille University Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2014
First Posted
August 19, 2016
Study Start
February 1, 2013
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
August 19, 2016
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will not share