Sawyer Kelly N, Mooney Michael, Norris Gregory, Devlin Thomas, Lundbye Justin, Doshi Pratik B, Hewett Jonathan Kyle, Kono Alan T, Jorgensen Jesse P, O'Neil Brian J
1 Department of Emergency Medicine, University of Pittsburgh School of Medicine , Pittsburgh, Pennsylvania.
2 Minneapolis Heart Institute Foundation , Minneapolis, Minnesota.
Ther Hypothermia Temp Manag. 2019 Mar;9(1):56-62. doi: 10.1089/ther.2018.0007. Epub 2018 Jun 8.
Targeted temperature management (TTM) is recommended postcardiac arrest. The cooling method with the highest safety and efficacy is unknown. The COOL-ARREST pilot trial aimed to evaluate the safety and efficacy of the most contemporary ZOLL Thermogard XP Intravascular Temperature Management (IVTM) system for providing mild TTM postcardiac arrest. This multicenter, prospective, single-arm, observational pilot trial enrolled patients at eight U.S. hospitals between July 28, 2014, and July 24, 2015. Adult (≥18 years old), out-of-hospital cardiac arrest subjects of presumed cardiac etiology who achieved return of spontaneous circulation (ROSC) were considered for inclusion. Patients were excluded if (1) awake or consistently following commands after ROSC, (2) significant prearrest neurological dysfunction, (3) terminal illness or advanced directives precluding aggressive care, and (4) severe hemodynamic instability or shock. Patient temperature was maintained at 33.0°C ± 0.3°C for a total of 24 hours followed by controlled rewarming (0.1-0.2°C/h). Logistic regressions were used to assess association of good functional outcome (modified Rankin Scale ≤3) measured at the time of hospital discharge with shockable rhythm (yes/no), age, gender, race/ethnicity, lay-rescuer cardiopulmonary resuscitation, time to basic life support (minutes), time to ROSC (minutes), lactate (mg/dL), and pH on admission. The ZOLL IVTM system was effective at inducing TTM (median time to target temperature from initiation, 89 minutes [interquartile range 42-155]). Adverse events most often included electrolyte abnormalities and dysrhythmias. Of patients surviving to hospital discharge, 16/20 patients had a good functional outcome. A total of 18 patients survived through 90-day follow-up, at which time 94% (17/18) of patients had good functional outcome. The COOL-ARREST pilot trial demonstrates high safety and efficacy of the ZOLL Thermogard XP IVTM system in the application of mild TTM postcardiac arrest. This observational trial also revealed noteworthy variability in the management of postcardiac arrest patients, particularly with the use of early withdrawal of life-sustaining therapy.
心脏骤停后推荐进行目标温度管理（TTM）。安全性和有效性最高的降温方法尚不清楚。COOL - ARREST试点试验旨在评估最先进的ZOLL Thermogard XP血管内温度管理（IVTM）系统在心脏骤停后提供轻度TTM的安全性和有效性。这项多中心、前瞻性、单臂观察性试点试验于2014年7月28日至2015年7月24日在美国八家医院招募患者。纳入标准为成年（≥18岁）、院外心脏骤停且推测为心脏病因并实现自主循环恢复（ROSC）的患者。若患者存在以下情况则被排除：（1）ROSC后清醒或持续能听从指令；（2）心脏骤停前存在严重神经功能障碍；（3）终末期疾病或有预立医嘱排除积极治疗；（4）严重血流动力学不稳定或休克。患者体温维持在33.0°C±0.3°C共24小时，随后进行控制性复温（0.1 - 0.2°C/小时）。采用逻辑回归评估出院时良好功能结局（改良Rankin量表≤3）与可电击心律（是/否）、年龄、性别、种族/族裔、非专业救援者心肺复苏、基本生命支持时间（分钟）、ROSC时间（分钟）、入院时乳酸水平（mg/dL）和pH值之间的关联。ZOLL IVTM系统在诱导TTM方面有效（从开始到目标温度的中位时间为89分钟[四分位间距42 - 155]）。不良事件最常见的包括电解质异常和心律失常。存活至出院的患者中，16/20例患者有良好的功能结局。共有18例患者存活至90天随访，此时94%（17/18）的患者有良好的功能结局。COOL - ARREST试点试验证明了ZOLL Thermogard XP IVTM系统在心脏骤停后应用轻度TTM时具有高安全性和有效性。这项观察性试验还揭示了心脏骤停后患者管理中存在显著差异，尤其是在使用早期撤除生命维持治疗方面。
