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临床试验/NCT02380482
NCT02380482已完成不适用

Myocardial Dysfunction at Early Phase of Traumatic Brain Injury : Evaluation by Two Dimensional and Speckle Tracking Transthoracic Echocardiography

University Hospital, Grenoble1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2014年12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
发起方
入组人数
40
试验地点
1
主要终点
left ventricular ejection fraction

研究概览

简要总结

Traumatic brain injury (TBI) is a frequent pathology leading to major morbidity and mortality in young people. Cerebral flood flow maintenance is a major goal directed therapy to improve the prognosis of the patient. Due to cerebral-myocardial interaction, a myocardial dysfunction might occur at the early phase of the traumatic brain injury. This myocardial dysfunction could be partly responsible for a decrease in cerebral blood flow. In such case, improving myocardial dysfunction may help to increase cerebral blood flow and improve patient prognosis. In clinical practice the easiest and non invasive way to explore myocardial dysfunction is with transthoracic echocardiography. The objective of this trial is to investigate myocardial dysfunction at the early phase of traumatic brain injury, compared with a controlled group without TBI.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •TBI patients
  • •Inclusion Criteria:
  • •Isolated and non opened traumatic brain injury
  • •18 - 65 years old
  • •Intubated and mechanically ventilated
  • •Glasgow score < or = 9 or
  • •Glasgow score between 9 and 13 (included) and Following Traumatic Coma Data Bank Tomographic Damages diffuse injuries type III or IV or mass lesion over 25ml and/or neurosurgical injuries
  • •Medical insurance

排除标准

  • •Treated major cardiovascular risks factors
  • •cardiovascular past medical history (acute cardiovascular event)
  • •Cardio thoracic surgery
  • •Brain dead status
  • •Inotrope drugs
  • •Severe polytraumatism
  • •Acute haemorrhage
  • •Non echogenic patient
  • •High level athlete
  • •Incapacitated person by law and pregnant women
  • •Discovery during echocardiography of underlying cardiomyopathy
  • •Urgent neurosurgery required
  • •Control patients
  • •Inclusion Criteria:
  • •Isolated and non opened traumatic brain injury
  • •18 - 65 years old
  • •Intubated and mechanically ventilated
  • •Paired with TBI patient on age, BMI and sex
  • •Undergoing urgent non severe surgery
  • •Medical insurance
  • •Exclusion Criteria:
  • •Traumatic brain injury
  • •Treated major cardiovascular risks factors
  • •cardiovascular past medical history (acute cardiovascular event)
  • •Cardio thoracic surgery
  • •Inotrope and vasopressive drugs
  • •Circulatory failure
  • •Non echogenic patient
  • •High level athlete
  • •Incapacitated person by law and pregnant women
  • •Discovery during echocardiography of underlying cardiomyopathy
  • •Urgent neurosurgery required

研究组 & 干预措施

Traumatic brain injury

Other

Two dimensional and speckle tracking transthoracic echocardiography in traumatic brain injured patients

  • Glasgow score < or = 9 or
  • Glasgow score between 9 and 13 (included) and Following Traumatic Coma Data Bank Tomographic Damages:

diffuse injuries type III or IV or mass lesion over 25ml and/or neurosurgical injuries

干预措施: Transthoracic echocardiography on TBI patients (Other)

Controls

Other

Two dimensional and speckle tracking transthoracic echocardiography in control patients paired with traumatic brain injured patient on age, BMI and sex with the following criteria:

  • Intubated and mechanically ventilated
  • Undergoing urgent non severe surgery

干预措施: Transthoracic echocardiography on control patients (Other)

结局指标

主要结局

left ventricular ejection fraction

时间窗: within the first 24 hours after injury

次要结局

  • Systolic strain rate by speckle tracking (in second)(within the first 24 hours after injury)
  • Diastolic strain rate by speckle tracking (in second)(within the first 24 hours after injury)
  • Systolic rotational velocity by speckle tracking (in degree by second)(within the first 24 hours after injury)
  • Diastolic rotational velocity by speckle tracking (in degree by second)(within the first 24 hours after injury)
  • Systolic twisting velocity by speckle tracking (in degree by second)(within the first 24 hours after injury)
  • Diastolic untwisting velocity by speckle tracking (in degree by second)(within the first 24 hours after injury)
  • Myocardial wall thickness (in millimeter)(within the first 24 hours after injury)
  • left ventricular diastolic function (cm/sec)(within the first 24 hours after injury)
  • Cardiac index(within the first 24 hours after injury)
  • tissue doppler imaging (cm/sec)(within the first 24 hours after injury)
  • right ventricular diastolic function(within the first 24 hours after injury)
  • right ventricular systolic function(within the first 24 hours after injury)
  • Strain evaluation by speckle tracking (in percentage of systolic duration)(within the first 24 hours after injury)

研究者

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

研究点 (1)

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