Long Term Follow-up of Cardiac Arrest Survivors Exposed to Ultra-rapid Cooling
NCT07028372
Summary
Less than 10% of patients eliciting out-of-hospital cardiac arrest (OHCA) survive, although 30% can be resuscitated by Emergency services before admission in Intensive Care Units (ICU). The majority succumb to Post-Cardiac Arrest Syndrome (PCAS). PCAS is associated with high mortality (60-70%) and morbidity. One proposed method of preventing the neurological and cardiac consequences of PCAS is to lower the body temperature to 33°C as quickly as possible. This approach is known as therapeutic hypothermia or Targeted Temperature Management (TTM). The Vent2Cool system, developed by Orixha, is a novel approach that enables the rapid induction of therapeutic hypothermia by using hypothermic Total Liquid Ventilation (TLV) to reach a protective temperature of 33°C within minutes. The OverCool feasibility study, which started in April 2025, is designed to validate the clinical performance and safety of an ultra-rapid cooling approach combining ultra-rapid hypothermia induction using the Vent2Cool system, and maintenance and rewarming using the ArcticSun system. The AfterCool study aims to evaluate long-term outcomes during a five-year follow-up of cardiac arrest survivors who were treated with ultrarapid cooling in the OverCool study.
Eligibility
Inclusion Criteria: * Age of 18 years and over * Cardiac arrest patient included in and alive at the end of the OverCool clinical investigation (28 days after the cardiac arrest) * Non-opposition from the patient or the trusted person or the close relative or parent obtained within 3 months after the end of the OverCool study Exclusion Criteria: * Follow-up refusal from patient of trusted person or the close relative or parent * Having being included in the OverCool clinical investigation but not submitted to the Vent2Cool procedure * Impossibility to reach the patient or the trusted person or the close relative or parent
Conditions4
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NCT07028372