Trial of Cooling for Patients With Excel Cryo Cooling System in Intracerebral Hemorrhage (ICH)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Temperature Reduction by 1 Degree Per Hour in the ICU Setting.
研究概览
简要总结
The purpose of this study is to determine if cooling the neck of patients with ICH decreases brain temperature. In addition, the investigators will determine if the device improves the delivery of oxygen to the brain. A third goal is to determine if cooling the neck lowers intracranial pressure (which is often times high in patients after ICH).
详细描述
This is a non-randomized device efficacy trial. Patients with >20cc Supratentorial ICH and an invasive brain temperature monitor (either Licox or Temperature sensing intracranial pressure device) will be enrolled after consent. The Excel Cryo Cooling System collar will be placed around neck in up to 20 patients for two hours. The goal is to determine the effectiveness of this device in cooling the brain. The collar is a standard neck collar used for patients after neck surgery with a modification that allows for the placement of a cooling pack in the collar that delivers the cold. During the study and for two hours after, the investigators will collect data concerning the brain temperature, body temperature, brain oxygen level and pressure both in the head and in the blood (blood pressure). The investigators will also collect demographic information about you (i.e. age, gender, medical risk factors) and information regarding your current disease process.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
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 with brain injury in the Neurological ICU.
- •Consent from the patient or surrogate decision maker.
- •Warfarin induced intracerebral hemorrhages only after correction of INR to <1.4.
排除标准
- •Cerebellar hemorrhages.
- •Moribund state where the physician team doesn't believe the patient will survive.
- •Patients who are being cared for with the intent of making them comfortable. DNR-CC (by Ohio law).
- •Known history of a blood dyscrasia such as CLL or essential thrombocytosis that could affect inflammation.
- •Known significant carotid artery stenosis (known >50% stenosis by history or incidental hospital imaging). This will not be specifically tested. Patients found to have significant stenosis later in the hospital stay will have their data interpreted separately as well as in the total group.
结局指标
主要结局
Temperature Reduction by 1 Degree Per Hour in the ICU Setting.
时间窗: During the 2 hours of neck cooling
Temperature reduction by 1 degree per hour in the Intensive Care Unit setting.
To Determine if Neck Cooling Affects Intracranial Pressure
时间窗: During 2 hours of neck cooling
To Determine if Neck Cooling Affects Brain Temperature.
时间窗: During the 2 hours of neck cooling
次要结局
未报告次要终点