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临床试验/NCT07099664
NCT07099664招募中不适用

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

University Hospital, Lille1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年10月3日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
90
试验地点
1
主要终点
Aortic VTI variation (%) measured by suprasternal doppler in percent of mean aortic VTI.

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
0 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

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

时间窗: During preoperative, after induction and fasting compensation, before incision.

次要结局

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

研究者

发起方
University Hospital, Lille
申办方类型
Other
责任方
Sponsor

研究点 (1)

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