Intensive Care Units, PediatricPEDIA-FICK-ICUNCT05741918
Cardiac Output Measurement in Pediatric Intensive Care Unit by Metabolic Monitor (Fick Method) (PEDIA-FICK-ICU)
A study testing Fick's method and Echocardiography in people with Intensive Care Units, Pediatric, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Cardiac output measurement is one of the most frequently used haemodynamic parameter used for intensive care unit (ICU) patients. In pediatric ICU, it is often measured with echocardiography that is a non-invasive method but is operator dependant and can't provide continuous monitoring. Read more about this study
- Who is it for?
- Ages 28 days to 17 years
- Conditions the study is for
- Intensive Care Units, Pediatric
- What is being tested?
- Fick's method and Echocardiography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 20 Aug 2023to Sep 2025
- Phase
- Interventional
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patient under 18 years old
- Patient over 10 kg
- Patient requiring intubation or intubated with a cuffed tube
- Patient requiring a central venous line in superior vena cava territory
Who cannot join
- Mechanical ventilation with leak
- Bad echogenicity preventing echocardiography
- Absence of written informed consent
- Patient not affiliated to French Health Insurance or not covered by public health insurance
- Patient with a legal protection
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
UH Montpellier
Montpellier
Arthur GAVOTTO, MD
About this study
Official title: Cardiac Output Measurement in Pediatric Intensive Care Unit by Metabolic Monitor (Fick Method) : Prospective Feasibility Study
Cardiac output measurement is one of the most frequently used haemodynamic parameter used for intensive care unit (ICU) patients. In pediatric ICU, it is often measured with echocardiography that is a non-invasive method but is operator dependant and can't provide continuous monitoring.
The goal of this clinical trial is to evaluate the feasibility of cardiac output measurement by Fick's method, non-invasive and allowing continuous monitoring, in comparison to echocardiography in pediatric intensive care unit.
- Conditions
- Intensive Care Units, Pediatric
- Being tested
- Fick's method, Echocardiography
- Keywords
- Cardiac output, Oxygen Consumption (VO2), Fick, Pediatric Intensive Care Unit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fick's methodDiagnostic test
Cardiac output measurement by Fick method
EchocardiographyDiagnostic test
Cardiac output measurement by echocardiography
| Study group | Role | What they receive |
|---|---|---|
| Pediatric Intensive Care Units Patients | Experimental | Patients under 18 admitted in pediatric intensive care unit Receives: Diagnostic Test: Fick's method; Diagnostic Test: Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-class correlation (or concordance) between the measurement of cardiac output (in ml/min) by Fick's method and by echocardiography
Measured: Up to day 3
Secondary outcomes (3)
Variations of cardiac output before and after Leg Raise Test
Measured: Up to day 3
Adverse events on the day of catheterization
Complications possibly due to Fick's method on the day of catheterization : pneumothorax, bleeding, rhythm disorder, gas embolism, failure to place, other
Measured: Up to 21 days
Adverse events on the day of catheter removal
Complications possibly due to Fick's method on the day of catheter removal : catheter thrombosis, catheter infection, non-functional oximetry catheter
Measured: Up to 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start20 Aug 2023
- Primary completionAug 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care Units, PediatricStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05741918
- Sponsor's protocol ID
- RECHMPL22_0227
- Acronym
- PEDIA-FICK-ICU
- Status last verified
- Aug 2024
- First submitted
- 13 Feb 2023
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Output Measurement in Pediatric Intensive Care Unit by Metabolic Monitor (Fick Method) : Prospective Feasibility Study
- ClinicalTrials.gov ID
- NCT05741918
- Acronym / sponsor ID
- PEDIA-FICK-ICU / RECHMPL22_0227
- Conditions
- Intensive Care Units, Pediatric
- Keywords
- Cardiac output, Oxygen Consumption (VO2), Fick, Pediatric Intensive Care Unit
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 20 Aug 2023 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 23 Feb 2023 (actual)
- 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.
Cardiac output measurement is one of the most frequently used haemodynamic parameter used for intensive care unit (ICU) patients. In pediatric ICU, it is often measured with echocardiography that is a non-invasive method but is operator dependant and can't provide continuous monitoring.
The goal of this clinical trial is to evaluate the feasibility of cardiac output measurement by Fick's method, non-invasive and allowing continuous monitoring, in comparison to echocardiography in pediatric intensive care unit.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric Intensive Care Units Patients | Experimental | Diagnostic Test: Fick's method, Diagnostic Test: EchocardiographyPatients under 18 admitted in pediatric intensive care unit |
Who may qualify
- Ages
- 28 days to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patient under 18 years old
- Patient over 10 kg
- Patient requiring intubation or intubated with a cuffed tube
- Patient requiring a central venous line in superior vena cava territory
Key exclusion criteria (5 listed)
- Mechanical ventilation with leak
- Bad echogenicity preventing echocardiography
- Absence of written informed consent
- Patient not affiliated to French Health Insurance or not covered by public health insurance
- Patient with a legal protection
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 |
|---|---|---|
| Fick's methodCardiac output measurement by Fick method | Diagnostic test | Pediatric Intensive Care Units Patients |
| EchocardiographyCardiac output measurement by echocardiography | Diagnostic test | Pediatric Intensive Care Units Patients |
Primary outcome
Intra-class correlation (or concordance) between the measurement of cardiac output (in ml/min) by Fick's method and by echocardiography
Time frame: Up to day 3
3 secondary outcomes
Variations of cardiac output before and after Leg Raise Test
Time frame: Up to day 3
Adverse events on the day of catheterization
Time frame: Up to 21 days
Adverse events on the day of catheter removal
Time frame: Up to 21 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fick's method and Echocardiography in people with Intensive Care Units, Pediatric, run by University Hospital, Montpellier 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 26 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arthur GAVOTTO, PH-U (+334.67.33.66.09, a-gavotto@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra-class correlation (or concordance) between the measurement of cardiac output (in ml/min) by Fick's method and by echocardiography (time frame: Up to day 3). 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 26 Aug 2024.