About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Short Form Health Survey (SF-36)
- Modified Rankin Score (mRS)
- Activity of Daily Living (ADL) questionnaire
- New York Heart Association (NYHA) Classification
- St George's Respiratory Questionnaire (SGRQ)
Treatment groups
Sponsors and collaborators
Assistance Publique - Hôpitaux de Paris
Lead sponsor
ORIXHA
Collaborator