Tissier Renaud, Taccone Fabio Silvio, Lamhaut Lionel, Vicaut Eric, Paublant Fabrice, Ricard Jean-Damien, Mercat Alain, Cariou Alain
Paris Est Créteil, INSERM, IMRB F-94010 Créteil, France.
Ecole Nationale Vétérinaire d'Alfort, IMRB, AfterROSC Network, F-94700 Maisons-Alfort, France.
Resusc Plus. 2025 Mar 10;23:100926. doi: 10.1016/j.resplu.2025.100926. eCollection 2025 May.
The therapeutic window within which induced hypothermia might be effective after cardiac arrest is still unknown. In animal cardiac arrest models, early induction and faster cooling are independently associated favorable outcome. However, induction of Ultra-Rapid Therapeutic Hypothermia (achieving core body temperature of 33.0 ± 0.5 °C within 60 min after the start of the procedure) still need to be evaluated in the human setting. Total liquid ventilation with temperature-controlled breathable liquids provided such rapid cooling (i.e. >15 °C/h cooling rate) in both small and large animals. This method was shown to improve neurological outcome in animals. A new medical device system, Vent2Cool, was developed for clinical use in the Intensive Care Unit to achieve ultra-rapid therapeutic hypothermia by total liquid ventilation to patients.
The non-blinded and single-arm OverCool pilot trial will evaluate the feasibility, cooling performance and safety of ultra-rapid therapeutic hypothermia by total liquid ventilation in 24 patients resuscitated after in- or out-of-hospital cardiac arrest. Inclusion criteria will include presumption to start ultra-rapid cooling procedure in the Intensive Care Unit within less than 120 min after resuscitation. The primary outcome will be the achievement of a core temperature of 33.0 ± 0.5 °C, as well as successful return to conventional gas ventilation within <60 min after procedure initiation. Secondary outcomes will include time to reach target temperature, vital status, systemic and pulmonary parameters and modified-Rankin Score at 28 days post- cardiac arrest.
The OverCool study is a pilot study to validate performance and safety of ultra-rapid therapeutic hypothermia using total liquid ventilation for resuscitated cardiac arrest patients.
NCT06798818. Authorized by the French "Agence nationale de sécurité du médicament et des produits de santé" and "Comité de Protection des Personnes" (Ethics Committee).
心脏骤停后诱导性低温可能有效的治疗窗仍不明确。在动物心脏骤停模型中，早期诱导和更快降温与良好预后独立相关。然而，超快速治疗性低温（在操作开始后60分钟内使核心体温达到33.0±0.5°C）在人体中的效果仍需评估。使用温度可控的可呼吸液体进行全液体通气在大小动物中均能实现如此快速的降温（即降温速率>15°C/小时）。该方法已被证明可改善动物的神经学预后。一种新的医疗设备系统Vent2Cool已被开发用于重症监护病房的临床应用，通过对患者进行全液体通气来实现超快速治疗性低温。
非盲单臂OverCool试点试验将评估在24例院内心脏骤停或院外心脏骤停复苏后的患者中，通过全液体通气进行超快速治疗性低温的可行性、降温性能和安全性。纳入标准将包括预计在复苏后120分钟内在重症监护病房开始超快速降温程序。主要结局将是核心体温达到33.0±0.5°C，以及在程序启动后<60分钟内成功恢复到传统气体通气。次要结局将包括达到目标温度的时间、生命体征、全身和肺部参数以及心脏骤停后28天的改良Rankin评分。
OverCool研究是一项试点研究，旨在验证对心脏骤停复苏患者使用全液体通气进行超快速治疗性低温的性能和安全性。
NCT06798818。获得法国“国家药品和健康产品安全局”及“保护人类委员会”（伦理委员会）授权。
Zotero 插件