Pediatric DisordersPF-ECHONCT02873494
PHYSIOFLOW/Comparison of Cardiac Output Measurement
An observational study of Pediatric Disorders, run by University Hospital, Lille at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 28 days to 10 years
- Conditions the study is for
- Pediatric Disorders
- What is being tested?
- PHYSIOFLOW - PF05 Lab1TM
- Type of treatment
- Medical device
- How many people
- 43 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2013to Feb 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 days to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: Child hospitalized in pediatric intensive care unit aged from 28 days to 10 years. Any change of treatment was performed during inclusion
Who may be able to join
- Children aged from 28 days to 10 years hospitalized in Pediatric ICU, including therapeutic support requires a hemodynamic assessment by ETT.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pediatric Disorders
- Being tested
- PHYSIOFLOW - PF05 Lab1TM
- Keywords
- Hemodynamic monitoring, cardiac output, Transthoracic echocardiography, Impedance cardiography, Child, Physioflow, pediatric intensive care unit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PHYSIOFLOW - PF05 Lab1TMDevice
| Study group | Role | What they receive |
|---|---|---|
| PHYSIOFLOW PF05 Lab1TM | Impedance cardiography Receives: Device: PHYSIOFLOW - PF05 Lab1TM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within the time hemodynamic assessment by echocardiography, less than 15 minutes.
Secondary outcomes (1)
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.
Measured: Within the time hemodynamic assessment by echocardiography, less than 15 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study startFeb 2013
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ASTRID BOTTE, PH, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02873494
- Sponsor's protocol ID
- 2012_25
- Other IDs
- 2012-A0132835
- Acronym
- PF-ECHO
- Status last verified
- Aug 2016
- First submitted
- 16 Sep 2014
- Last updated
- 19 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impedance Cardiography by PhysioFlow® for Non-invasive Cardiac Output Monitoring: a Comparison With Trans-thoracic Echocardiography in Pediatric Intensive Care Patients.
- ClinicalTrials.gov ID
- NCT02873494
- Acronym / sponsor ID
- PF-ECHO / 2012_25
- Conditions
- Pediatric Disorders
- Keywords
- Hemodynamic monitoring, cardiac output, Transthoracic echocardiography, Impedance cardiography, Child, Physioflow, pediatric intensive care unit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 19 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PHYSIOFLOW PF05 Lab1TM | – | Device: PHYSIOFLOW - PF05 Lab1TMImpedance cardiography |
Who may qualify
- Ages
- 28 days to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Child hospitalized in pediatric intensive care unit aged from 28 days to 10 years. Any change of treatment was performed during inclusion
Key inclusion criteria (1 listed)
- Children aged from 28 days to 10 years hospitalized in Pediatric ICU, including therapeutic support requires a hemodynamic assessment by ETT.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PHYSIOFLOW - PF05 Lab1TM | Device | PHYSIOFLOW PF05 Lab1TM |
Primary outcome
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.
1 secondary outcome
CO and CI measures
Time frame: Within the time hemodynamic assessment by echocardiography, less than 15 minutes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ASTRID BOTTE, PH principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Disorders, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2016.