Practical Efficiency of Coupling Targeted Temperature Management to Brain Temperature Rather Than Systemic Temperature in Severe Brain Injury (BRAIN TTM)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- The percentage of time with brain temperature between (36.5 ± 0.5 °C)
研究概览
简要总结
In severe brain-injured patients, it is recommended to strictly control the fever in order to limit brain damage (objective of neuroprotection) via the targeted temperature management (TTM). In the guidelines, the target temperature is the systemic temperature, just for practical reasons (brain temperature not being monitored in most polyvalent ICU). However, in NICU, the brain temperature is monitored routinely via the Intra-Cerebral Pressure (ICP) sensor. Since in the febrile brain-injured patients the objective of the TTM is neuroprotection, it would be more appropriate to target temperature control over the cerebral temperature.
The objective of this study is to evaluate the efficacy of TTM directly coupled to the brain temperature.
Adult patients with brain injury requiring ICP monitoring (Pressio 2, Sophysa France) and fever requiring TTM (cerebral greater than or equal to 38.5 °C) will be enrolled. The TTM will be carried out according to the usual methods of the investigator's service: external cooling devices coupled with cerebral temperature (Artic Sun, Bard France), including two phases: the cooling phase (H0 to H3) and the maintenance phase (from H3 to the end of the cooling).
Two groups will be formed. In the interventional group, coupling of the TTM will be carried out to the cerebral temperature. In the control group, coupling of the TTM will be carried out to the systemic temperature measured at the bladder site.
The primary outcome will be the percentage of time during which the cerebral temperature will be measured within recommended target temperature range (i.e. 36 to 37 °C) during the maintenance phase (H3 to H12): comparison of averages. Cerebral hemodynamic parameters (ICP, transcranial doppler, and brain tissue oxygen partial pressure if available) will also be collected, in order to be correlated with the delta temperature (cerebral temperature minor systemic temperature).
No medical device will be put in place specifically for the need of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients 18 years of age or older
- •hospitalized patient in neuro-resuscitation with peak monitoring with cerebral temperature measurement by an intra-parenchymal sensor (Sophysa®)
- •patient in hyperthermia (TC ≥ 38.5 °c) and in a situation of brain pain
排除标准
- •patient benefiting from a legal protection measure
- •pregnant or breastfeeding woman
- •previous participation in this study
研究组 & 干预措施
Cerebral temperature target
CCT performed by the external cooling device with cerebral temperature target, measured by a intracranial sensor (coupled to the intracranial pressure device)
干预措施: external cooling with the xxxxx device (Device)
Systemic temperature target
CCT performed by the external cooling device with systemic temperature target, measured by a bladder sensor (coupled to the vesal probe, according to the standard service protocol).
干预措施: external cooling with the xxxxx device (Device)
结局指标
主要结局
The percentage of time with brain temperature between (36.5 ± 0.5 °C)
时间窗: 12 hours
The percentage of time during which the measured brain temperature is included in the target temperature range (36.5 ± 0.5 °C), during the maintenance phase (averages comparison).
次要结局
未报告次要终点