HemodynamicKid's FMNCT07099664
Use of the Aortic Time-velocity Integral Via Suprasternal Ultrasound to Search Preload Dependence in Paediatric Surgery : Kid's Fluid Management (FM)
An observational study of Hemodynamic, run by University Hospital, Lille at 1 site in France.
Trial summary
After major surgery, fluid overload is associated with an increase of morbidity and mortality. Fluid administration should therefore be given wisely. However, there is a paucity of monitor to predict preload dependence in paediatric anaesthesia. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Hemodynamic
- What is being tested?
- Measurement of aortic Vmax and VTI with suprasternal doppler.
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 3 Oct 2025to Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patient under 18 admitted to paediatric operating room for a surgical intervention, an endoscopy, an interventional radiology procedure or an imagery and needing a general anaesthesia
Who may be able to join
- Patient under 18 admitted to paediatric operating room for a surgical intervention, an endoscopy, an interventional radiology procedure or an imagery and needing a general anaesthesia.
Who cannot join
- Condition preventing a suprasternal ultrasound (tracheostomy, spinal immobilization, suprasternal bandage)
- Pathology disturbing respiratory variation of left ventricular stroke volume (PAH, constrictive pericarditis, pericardial effusion, right ventricular dysfunction, complex congenital heart disease, aortic coarctation, patent ductus arteriosus
- Every medical condition where Berry's rule of fasting compensation could be unsafe (anuric kidney failure, oedema, heart failure with reduce left ventricular ejection fraction, patient under vasoactive drugs
- Opposition to the participation in the study
- Pregnant women
- Patient with no security coverage
- Inability to determine baseline cardiac output
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
chu de Lille
Lille
Martin DUBERNET, +33 3 20 44 59 62, Martin.DUBERNET@chu-lille.fr
About this study
Official title: Use of the Aortic Time-velocity Integral (VTI) Via Suprasternal Ultrasound to Search Preload Dependence in Paediatric Surgery : Kid's Fluid Management (FM)
After major surgery, fluid overload is associated with an increase of morbidity and mortality.
Fluid administration should therefore be given wisely. However, there is a paucity of monitor to predict preload dependence in paediatric anaesthesia.
The aim of this study is to determine if VTI variation, measured through the suprasternal window, with a cardiac doppler probe, can predict preload dependence.
Indeed, cardiac probe are present in most operating room and suprasternal window is reachable in most surgical case, which should allow VTI monitoring for the vast majority of our patient.
- Conditions
- Hemodynamic
- Being tested
- Measurement of aortic Vmax and VTI with suprasternal doppler.
- Keywords
- Suprasternal doppler, paediatric anaesthesia, hemodynamic, fluid management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of aortic Vmax and VTI with suprasternal doppler.Diagnostic test
Measurement of aortic Vmax and VTI with suprasternal doppler. Measurement of VTI variation and cardiac output after general anaesthesia. After preoperative fasting compensation, measurement of cardiac output (CO). Search of a difference in the suprasternale VTI variability between the patients who have increased their CO after fasting compensation and the patient who haven't.
| Study group | Role | What they receive |
|---|---|---|
| Measurement of VTI variation and cardiac output after general anaesthesia. | Measurement of VTI variation and cardiac output after general anaesthesia. Patients responding to volume expansion (more than 10% increase of cardiac output measured by transthoracic ultrasound after a 10ml/kg perfusion of cristalloids) Receives: Diagnostic Test: Measurement of aortic Vmax and VTI with suprasternal doppler. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aortic VTI variation (%) measured by suprasternal doppler in percent of mean aortic VTI.
Measured: During preoperative, after induction and fasting compensation, before incision.
Secondary outcomes (3)
Proportion of patient (%) in whom we can use suprasternal aortic measurements.
Measured: During preoperative period, after induction and fasting compensation, before incision.
Optimal threshold of aortic VTI variation (%) measured by suprasternal doppler to determine wether the patient is preload dependant or independent as defined above.
Optimal threshold of aortic VTI variation (%) measured by suprasternal doppler to determine wether the patient is preload dependant or independent as defined above (more than 10% increase of cardiac output measured by transthoracic ultrasound after a 10mL/kg perfusion of cristalloids OR not).
Measured: During preoperative period, after induction and fasting compensation, before incision.
Correlation between : - fasting duration in hours, determined by patient or parent interrogation. - preload dependence as defined above. More than one outcome measure appears to be described.
Correlation between :
- fasting duration in hours, determined by patient or parent interrogation.
- preload dependence as defined above (increase of 10% or more of stroke volume measured by transthoracic ultrasound after a 10mL/kg perfusion of cristalloids).
More than one outcome measure appears to be described.
Measured: During preoperative period, after induction and fasting compensation, before incision.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start3 Oct 2025
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodynamicStudies 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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07099664
- Sponsor's protocol ID
- 2023_0708
- Other IDs
- 2024-A01473-44
- Acronym
- Kid's FM
- Status last verified
- May 2026
- First submitted
- 30 Jun 2025
- Last updated
- 22 May 2026
- 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 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the Aortic Time-velocity Integral (VTI) Via Suprasternal Ultrasound to Search Preload Dependence in Paediatric Surgery : Kid's Fluid Management (FM)
- ClinicalTrials.gov ID
- NCT07099664
- Acronym / sponsor ID
- Kid's FM / 2023_0708
- Conditions
- Hemodynamic
- Keywords
- Suprasternal doppler, paediatric anaesthesia, hemodynamic, fluid management
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 3 Oct 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 1 Aug 2025 (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.
After major surgery, fluid overload is associated with an increase of morbidity and mortality.
Fluid administration should therefore be given wisely. However, there is a paucity of monitor to predict preload dependence in paediatric anaesthesia.
The aim of this study is to determine if VTI variation, measured through the suprasternal window, with a cardiac doppler probe, can predict preload dependence.
Indeed, cardiac probe are present in most operating room and suprasternal window is reachable in most surgical case, which should allow VTI monitoring for the vast majority of our patient.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Measurement of VTI variation and cardiac output after general anaesthesia. | – | Diagnostic Test: Measurement of aortic Vmax and VTI with suprasternal doppler.Measurement of VTI variation and cardiac output after general anaesthesia. Patients responding to volume expansion (more than 10% increase of cardiac output measured by transthoracic ultrasound after a 10ml/kg perfusion of cristalloids) |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patient under 18 admitted to paediatric operating room for a surgical intervention, an endoscopy, an interventional radiology procedure or an imagery and needing a general anaesthesia
Key inclusion criteria (1 listed)
- Patient under 18 admitted to paediatric operating room for a surgical intervention, an endoscopy, an interventional radiology procedure or an imagery and needing a general anaesthesia.
Key exclusion criteria (7 listed)
- Condition preventing a suprasternal ultrasound (tracheostomy, spinal immobilization, suprasternal bandage)
- Pathology disturbing respiratory variation of left ventricular stroke volume (PAH, constrictive pericarditis, pericardial effusion, right ventricular dysfunction, complex congenital heart disease, aortic coarctation, patent ductus arteriosus
- Every medical condition where Berry's rule of fasting compensation could be unsafe (anuric kidney failure, oedema, heart failure with reduce left ventricular ejection fraction, patient under vasoactive drugs
- Opposition to the participation in the study
- Pregnant women
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 |
|---|---|---|
| Measurement of aortic Vmax and VTI with suprasternal doppler.Measurement of aortic Vmax and VTI with suprasternal doppler. Measurement of VTI variation and cardiac output after general anaesthesia. After preoperative fasting compensation, measurement of cardiac output (CO). Search of a difference in the suprasternale VTI variability between the patients who have increased their CO after fasting compensation and the patient who haven't. | Diagnostic test | Measurement of VTI variation and cardiac output after general anaesthesia. |
Primary outcome
Aortic VTI variation (%) measured by suprasternal doppler in percent of mean aortic VTI.
Time frame: During preoperative, after induction and fasting compensation, before incision.
3 secondary outcomes
Proportion of patient (%) in whom we can use suprasternal aortic measurements.
Time frame: During preoperative period, after induction and fasting compensation, before incision.
Optimal threshold of aortic VTI variation (%) measured by suprasternal doppler to determine wether the patient is preload dependant or independent as defined above.
Time frame: During preoperative period, after induction and fasting compensation, before incision.
Correlation between : - fasting duration in hours, determined by patient or parent interrogation. - preload dependence as defined above. More than one outcome measure appears to be described.
Time frame: During preoperative period, after induction and fasting compensation, before incision.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- 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.
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 Hemodynamic, 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: looking for participants now, as of the sponsor's last update on 22 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martin DUBERNET, Dr (+33 3 20 44 59 62, Martin.DUBERNET@chu-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aortic VTI variation (%) measured by suprasternal doppler in percent of mean aortic VTI. (time frame: During preoperative, after induction and fasting compensation, before incision.). 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 22 May 2026.