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A prospective, multicenter pilot study to evaluate the feasibility and safety of using the CoolGard trade mark System and Icy trade mark catheter following cardiac arrest.

机译:一项前瞻性,多中心的前瞻性研究,用于评估心脏骤停后使用CoolGard商标系统和Icy商标导管的可行性和安全性。

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Background: Cardiac arrest causes devastating neurological morbidity and mortality. Mild/moderate hypothermia is neuroprotective after global cerebral ischemia. More rapid controlled attainment of the target temperature may increase efficacy. Methods: We assessed the safety and feasibility of endovascular cooling in a single arm study of comatose patients who had been successfully resuscitated after cardiac arrest. Core temperature was reduced to a target of 33 degrees C for 24h using a closed loop endovascular system placed in the inferior vena cava, followed by controlled rewarming. Primary outcomes were speed and accuracy of cooling, survival and GOS after 30 days. Results: Thirteen patients were enrolled, six male, age [Formula: see text] years. Time from cardiac arrest to return of spontaneous circulation was 14.3min (range 5-32.5). It took 3h and 39min (median 210min, IQ 80-315) to reach 33 degrees C; cooling averaged [Formula: see text] degrees C/h (range 0.22-1.12 degrees C/h). Temperature was tightly maintained for all patients averaging [Formula: see text] degrees C. Rewarming lasted [Formula: see text] h. Five patients (38%) had 30-day Glasgow Outcome Scores of 1-2. Four patients died, none related to the hypothermia procedure. No unanticipated or procedure-related adverse events occurred. Conclusion: In comatose survivors of cardiac arrest, hypothermia via endovascular methods is safe and feasible, and target temperatures can be achieved and controlled rapidly and precisely. More studies are needed to assess the efficacy of rapid endovascular hypothermia after cardiac arrest.
机译:背景:心脏骤停会导致严重的神经系统疾病和死亡。轻度/中度低温对全脑缺血后具有神经保护作用。更快地控制达到目标温度可以提高功效。方法:我们在单臂研究中评估了心脏骤停后成功复苏的昏迷患者的安全性和可行性。使用放置在下腔静脉中的闭环血管内系统将核心温度降低到33摄氏度的目标,持续24小时,然后进行可控的预热。主要结果是30天后降温的速度和准确性,生存率和GOS。结果:招募了13名患者,其中6名男性,年龄[公式:参见文本]岁。从心脏骤停到自然循环恢复的时间为14.3分钟(范围5-32.5)。花了3小时39分钟(中值210分钟,IQ 80-315)达到33摄氏度;平均冷却[公式:参见文字]摄氏度/小时(范围0.22-1.12摄氏度/小时)。所有患者的体温均严格保持在[°]。持续升温[°]。 5名患者(38%)的30天格拉斯哥结果得分为1-2。 4例患者死亡,与低温手术无关。没有发生意外或与程序相关的不良事件。结论:在昏迷的心脏骤停幸存者中,通过血管内方法进行体温过低是安全可行的,可以快速准确地达到并控制目标温度。需要更多的研究来评估心脏骤停后快速血管内低温的疗效。

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