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临床试验/NCT01796015
NCT01796015已完成不适用

Intracranial Hypertension Detection Using Optic Nerve Sheath Diameter Measurement in Children

Hospices Civils de Lyon4 个研究点 分布在 1 个国家目标入组 230 人开始时间: 2011年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
230
试验地点
4
主要终点
Primary (sensitivity and specificity of echographic measurement of ONSD)

研究概览

简要总结

Intracranial hypertension (ICH) is a mortality risk factor in severe traumatic brain injury (TBI), in purulent meningitis, in hepatic encephalopathy and in Reye's syndrome. It is also a risk factor for severe neurologic sequelae in survivors. Intracranial pressure (ICP) monitoring is likely to guide therapeutics, and certain research on adults or on children, suggest that IH therapeutic approach, for instance for bacterial meningitis, would improve the prognosis. Two monitoring techniques are currently recommended. They are reference methods for ICP measure :

  • monitoring with intraventricular catheter,
  • intra-parenchymal monitoring using optical fiber catheter. Non invasive methods have been suggested, including ultrasound measurement of optic nerve sheath diameter (ONSD) which is the most interesting one. The ONSD measured ultrasonically is correlated with ICP level in adults with severe TBI. A diameter over 5,9 mm predicts ICH within the first 24 hours. In children, ONSD average values have been worked out, and an ONSD increase is found in children suffering from hydrocephalus with IH and in children with TBI. ICH precocious detection is fundamental in children sensitive to ICH because their cerebral development is not finished yet. Difficulties met for ICP monitoring implementation in infants and its invasive nature are often disliked by clinicians. A non-invasive exam is then essential to allow a better care of children with ICH in intensive care unit.

研究设计

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

入排标准

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

入选标准

  • For the 97 patients:
  • children from 2 months to 16 years
  • in the intensive care unit
  • TBI : moderate (GCS between 9 and 12) to severe (GCS <9), whatever the mechanism involved
  • informed consent form signed by parents
  • Non inclusion Criteria:
  • obesity (BMI > 97th percentile for the age)
  • patient already under replacement therapy.
  • patient taking AEDs
  • patient with long-term systemic corticosteroid therapy
  • history of neurological disease or learning difficulties
  • no covered by a national health insurance

排除标准

  • 未提供

研究组 & 干预措施

For the 97 patients

Other
  • day 0: ultrasound of ONSD (= 4 measurements: 1 transverse and 1 sagittal for each eye) + transcranial Doppler at T-15 (15 minutes before ICP measurement), within 1h following ICP measurement, and one more measurement is to be done if significant ICP variations are noticed (variation over 15 mmHg during at least 5 minutes)
  • day 1: ONSD ultrasound + transcranial Doppler in the morning and one more measurement is to be done if significant ICP variations are noticed (variation over 15 mmHg during at least 5 minutes)
  • days 2 and 3 : same as day 1
  • when leaving the intensive care unit: Pediatric Overall Performance Category (POPC) scale

干预措施: ONSD ultrasound (Other)

For the control group

Other

one single ONSD in addition to their usual care (4 measurements: 1 transverse and 1 sagittal for each eye) in the morning in absence of painful sensation

干预措施: ONSD ultrasound (Other)

For the learning curve

Other

minimum 15 ONSD ultrasounds will be performed by each of the 15 intensive care doctor or interns expected. One ONSD ultrasound corresponds to 2 measurements: 1 transverse and 1 sagittal. Each volunteer will have maximum 30 ONSD ultrasound measures over a 1 month period.

干预措施: ONSD ultrasound (Other)

结局指标

主要结局

Primary (sensitivity and specificity of echographic measurement of ONSD)

时间窗: To determine diagnostic performance (sensitivity and specificity) of ICH thanks to ultrasound measurement of ONSD, (15 minutes ,before invasive ICP monitoring)

Sensitivity and specificity of echographic measurement of the ONSD (mean value of both eyes), taken 15 minutes ,before invasive ICP monitoring, regarding detection of ICH in children with neurological injury, as compared to reference method for ICH detection (ICP monitoring with intraventricular catheter).

次要结局

  • Secondary outcome (1. To draw learning curves before the study begins to find out the number of ultrasound measurement needed)(1. To draw learning curves before the study begins to find out the number of ultrasound measurement needed (day 0))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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