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Recruiting NCT07099664

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

— Observational Hemodynamic

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In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Measurement of aortic Vmax and VTI with suprasternal doppler..
Who it may be relevant to
Registry conditions: Hemodynamic. Basic parameters: 0 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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)

Overview

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.

Interventions

  • Diagnostic test 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.

Primary outcome measures

  • 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 outcome measures (3)
  • 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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • chu de Lille — Lille

Identifiers

NCT: NCT07099664 · 2023_0708 · 2024-A01473-44

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗