Study of PtiO2 Variation by Body Temperature and Capnia in Severe Head Trauma Patients With Intracranial Refractory Hypertension Treated With Targeted Temperature Control
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Changes in PbtO2 gross values during the targeted temperature control phase
研究概览
简要总结
Serious head trauma is a common and pathology and responsible of high morbidity and mortality. The major challenge, from the very first hours, is to limit cerebral ischemia by controlling secondary brain injury factors.
These parameters must be integrated early in order to guide the better cerebral resuscitation. Brain monitoring is multimodal:transcranial Doppler, intracranial pressure sensor, cerebral tissue pressure in O2.
In the case of refractory intracranial hypertension to well-conducted medical treatment, targeted temperature control showed its efficacy on the control of intracranial pressure.
There are few data in the literature on PbtO2 modifications during therapeutic hypothermia.
PbtO2 monitoring is now commonly used according to literature data, showing the benefit of the latter but the interpretation of its values during the phase of targeted temperature control is not known. Due to the lack of data on the variation of values of PbtO2 during the hypothermia phase, values falsely comfortable or falsely weak could lead respectively to a lack of support of an episode of tissue hypoxia or the introduction of unjustified aggressive therapeutics.
详细描述
This is a prospective, non-interventional, mono-centric study at surgical intensive care unit at Brest medical university hospital.
This study will be conducted in a reference center for the management of patients with traumatic brain injury, who is used to collect prospective data.
The clinical research structure of Brest Medical University allows data analysis and the investigators have the clinical knowledge for their interpretation.
After verification of the inclusion and non-inclusion criteria and information of the family (parent or relative) or the holder of parental authority, patients will be included in order of arrival in the service.
The population studied is the trauma brain injured patients with an initial Glasgow coma scale of less than 8 at pre-hospital care or neurological impairment with Glasgow Coma Scaleless than 8 in the first 24 hours after admission to intensive care.
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
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age> 15 years
- •severe traumatic brain injury defined by an initial Glasgow Coma Scale score less than 8 or neurological impairment in the first 24 hours with Glasgow less than 8,
- •brain hypertension refractory despite usual sedation and control of ACSOS (ICP> 20mmHg for more than 15 minutes over a period of one hour)
- •Participation Agreement.
排除标准
- •initial bilateral mydriasis
- •no information of the family
- •refusal of participation.
结局指标
主要结局
Changes in PbtO2 gross values during the targeted temperature control phase
时间窗: 1 year (through study completion)
Evaluated at the time T0 before induction of the targeted control of the temperature, at time T1: the first hour of the targeted temperature control phase (\<35 ° C), at time T2: during the stability phase of the temperature (\<35 ° C) defines as two successive hours of hypothermia, at time T3 defines as 6 hours at a stable temperature under hypothermia, then once a day until the control phase targeted temperature stops.
次要结局
- Changes in PtiO2 gross values during hypercapnia test(1 year (through study completion))