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临床试验/NCT04196543
NCT04196543已完成不适用

Interest of a Post-operative Ultrasound With Systematic Use of Ultrasonic Contrast in the Follow-up of Aortic Endoprosthesis: Prospective Study at the University Hospital of Nice

Centre Hospitalier Universitaire de Nice1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年2月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
measurement of anterior-posterior diameters according to 4 aortic endoprosthesis incidences after PCUS injection in immediate post-operative

研究概览

简要总结

This is a prospective study conducted on a population with an aortic endoprosthesis in the context of an abdominal aortic aneurysm. The study's objective is to standardize the ultrasound methodology in the monitoring of aortic endoprosthesis in immediate post-operative care by comparing the results with CT-scan (gold standard). To improve ultrasound methodology, the investigators propose to use the VESMA protocol for ultrasound diameter measurement at four incidences. In addition, the use of ultrasonic contrast agents increases the accuracy of vascular structures, the quality of the ultrasound blood flow image and the duration of signal enhancement. This makes it possible to visualize small gauge vessels and those with slow flows. In this way, the investigators could improve the ultrasound technique for measuring aneurysm bag diameters and endoleak detection. Moreover, the toxicity of iodinated contrast agents is the third cause of acute renal failure in hospitalized patients and is all the more frequent when the investigators increase injections. Improving the quality of ultrasound investigations for the monitoring of aortic endoprosthesis would therefore allow us to reduce the number of CT-scan performed in this population and thus reduce irradiation and the injection of nephrotoxic products. Thereby, the investigators would like to integrate the technique into the systematic follow-up of patients who have benefited from the placement of an aortic endoprosthesis by replacing the CT-scan.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

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

入选标准

  • Patients over 18 years of age.
  • Abdominal aortic aneurysm treated with aortic stent.
  • Signature of informed consent.
  • Person affiliated or beneficiary of a social security scheme

排除标准

  • Hypersensitivity to sulphur hexafluoride or to these excipients (Macrogol 4000, Distearoylphosphatidylcholine, Dipalmitoylphosphatidylglycerol sodé, Palmitic acid).
  • Right-left shunt patient
  • Patient with severe pulmonary hypertension (pulmonary blood pressure > 90 mm Hg),
  • Patient with uncontrolled systemic hypertension
  • Adult patients with respiratory distress syndrome.
  • Dobutamine patient in patients with a pathology suggesting cardiac instability
  • Hypercoagulation, recent thromboembolic accident
  • Fenestrated aortic stent
  • Pregnant or nursing woman.
  • Severe heart failure.
  • Person deprived of liberty by judicial or administrative decision.
  • Person subject to legal protection.

结局指标

主要结局

measurement of anterior-posterior diameters according to 4 aortic endoprosthesis incidences after PCUS injection in immediate post-operative

时间窗: 1 day

detection of endoleaks after PCUS injection in immediate post-operative

时间窗: 1 day

measurement of anterior-posterior diameters of endoleaks after PCUS injection in immediate post-operative

时间窗: 1 day

次要结局

  • Description of endoleaks after PCUS injection in immediate post-operative(1 day)
  • Description of exit doors of heart after PCUS injection in immediate post-operative(1 day)
  • Description of their flows after PCUS injection in immediate post-operative(1 day)
  • Description of maximum circulatory speeds after PCUS injection in immediate post-operative(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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