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临床试验/NCT02090881
NCT02090881已完成不适用

Comparison of a Portable and Non-Portable Ultrasound Machine in the Evaluation of Children With Sickle Cell Disease - A Pilot Study

Imperial College Healthcare NHS Trust2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2016年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
2
主要终点
Measurement of Time Average Mean of the Maximum (TAMM) in cm/Sec in Cerebral Arteries Using 2 Different Ultrasound Machines.

研究概览

简要总结

Sickle cell disease (SCD) affects haemoglobin - the molecule in blood cells which carries oxygen. It causes red blood cells to become abnormal crescent (or sickle)- shaped. Sickled red blood cells cannot travel through small blood vessels as easily as normal red blood cells which can lead to blockages. This means that oxygen may be prevented from getting to where it is needed. Individuals with sickle cell disease also suffer form abnormality in the lining of their blood vessels, which contributes to the damage.

Damage and blockage can occur in the blood vessels in the brain and means that children with sickle cell disease have a significant risk of suffering from strokes. Research has shown that transcranial Doppler ultrasonography can be used in this setting to identify children at most risk of getting strokes.

Ultrasound is therefore used in children with sickle cell disease to measure the blood flow in the vessels in the brain. This research has formed the basis of the National Health Service (NHS) Standard of Care for Sickle Cell Disease in the United Kingdom (UK) which uses transcranial Doppler ultrasonography at once a year to screen children with sickle cell disease aged 2 to 16.

Ultrasound is used because it is portable, does not uses ionising radiation such as x-rays, is non-invasive and gives good results. However, the results are dependent on the operator. This means that the screening service is provided by centres of excellence with experienced scanning staff visiting clinics in smaller hospitals with portable machines. There is a lack of research comparing the use of portable machines to laboratory-based machines. This is important because screening can identify children at high risk of stroke and may be used by clinical staff to make a decision about the care of the child.

详细描述

Please see above

研究设计

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

入排标准

年龄范围
2 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Clinical Diagnosis of Sickle Cell Disease
  • Under surveillance as part of the NHS Sickle Cell & Thalassaemia Screening Programme
  • Children between the ages of 2 - 16 years old. Those under 16 years of age must be accompanied by a responsible adult.

排除标准

  • Participants older than 16 years of age as this is outside the scope of the sickle cell screening programme.
  • Individuals unable to give fully informed and voluntary consent.
  • Individuals with inadequate temporal windows as it will not be possible to record measurements of velocity.

结局指标

主要结局

Measurement of Time Average Mean of the Maximum (TAMM) in cm/Sec in Cerebral Arteries Using 2 Different Ultrasound Machines.

时间窗: 4 months

A flow phantom was used to compare Time average mean maximum velocity measurements from a Philips IU-22 and Zonare Z-One ultrasound machine. 25 children with SCD (aged 2-15 years) attending the outpatient clinic at St. Mary's Hospital, Imperial College Healthcare NHS Trust as part of the NHS Sickle Cell \& Thalassaemia (SC\&T) screening programme, were studied. The Time Averaged Mean of the Maximum (TAMM) velocities in the middle cerebral artery (MCA) and stroke risk categorisation using the two ultrasound machines were compared.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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