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

Официальное название

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

Обзор

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.

Вмешательства

• Диагностический тест 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.

Первичные конечные точки

• Aortic VTI variation (%) measured by suprasternal doppler in percent of mean aortic VTI. [Срок оценки: During preoperative, after induction and fasting compensation, before incision.]

Вторичные конечные точки (3)

• Proportion of patient (%) in whom we can use suprasternal aortic measurements. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: During preoperative period, after induction and fasting compensation, before incision.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 1 центр

• chu de Lille — Lille

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗