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NCT Number: NCT07099664

Use of the Aortic Time-velocity Integral 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.

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Key information

Conditions

Hemodynamic

Age range

0 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Aortic VTI variation (%) measured by suprasternal doppler in percent of mean aortic VTI.

    Time frame: During preoperative, after induction and fasting compensation, before incision.

Secondary outcomes

  1. Proportion of patient (%) in whom we can use suprasternal aortic measurements.

    Time frame: During preoperative period, after induction and fasting compensation, before incision.

  2. 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.

    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).

  3. 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.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Julien COROUGE, Dr

CONTACT

[email protected]

+33 3 20 44 59 62

Martin DUBERNET, Dr

CONTACT

[email protected]

+33 3 20 44 59 62

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

Use of the Aortic Time-velocity Integral (VTI) Via Suprasternal Ultrasound to Search Preload Dependence in Paediatric Surgery : Kid's Fluid Management (FM)

Acronym: Kid's FM

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 1, 2025
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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