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Long Term Follow-up of Cardiac Arrest Survivors Exposed to Ultra-rapid Cooling

Recruitingn/aAges 18 Years - anyAllAssistance Publique - Hôpitaux de Paris
NCT07028372 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • 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)
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Where

2 sites
Angers University Hospital, Medical Intensive Care Unit, Vent'Lab
Angers, France
AP-HP Centre, Cochin Hospital, Medical Intensive Care Unit
Paris, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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