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.
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
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
Cardiac arrest patient included in and alive at the end of the OverCool clinical investigation (28 days after the cardiac arrest)
Cohort
Prospective
Short Form Health Survey (SF-36)
Other interventionHeath-related quality-of-life is assessed using the SF-36 questionnaire, which is administered at the inclusion visite, then at month 6, year 1, year 2, year 3, year 4 and year 5, in the form of a telephone interview.
Modified Rankin Score (mRS)
Other interventionThe degree of disability/dependence is evaluated using the mRS scale at the inclusion visite, then at month 6, year 1, year 2, year 3, year 4 and year 5, via telephone interview.
Activity of Daily Living (ADL) questionnaire
Other interventionLevel of independence is evaluated using the ADL questionnaire, which is administered at the inclusion visite, then at month 6, year 1, year 2, year 3, year 4 and year 5, in the form of a telephone interview.
New York Heart Association (NYHA) Classification
Other interventionThe extent of heart failure is assessed using the NYHA functional classification at the inclusion visite, then at month 6, year 1, year 2, year 3, year 4 and year 5, via telephone interview.
St George's Respiratory Questionnaire (SGRQ)
Other interventionRespiratory status is assessed using the SGRQ questionnaire at the inclusion visite, then at month 6, year 1, year 2, year 3, year 4 and year 5, via telephone interview.
Life status at 5 years
The primary endpoint is the life status at 5 years assessed by phone interview. Whenever possible, life status will be confirmed by reviewing the medical record.
Suspected cause of death
The suspected cause of death in the event of a death. Data are collected via interview. If the deceased is rehospitalised or receives additional care in a hospital that shares a medical database with centres participating in the Aftercool study, the information will be confirmed by reviewing the medical record.
Rehospitalization
Data are collected via interview. If a participant is rehospitalised or requires additional hospital care, and if that hospital shares a medical database with the centres of the Aftercool study, the information will be confirmed by reviewing the medical record.
Modified Rankin Scale (mRS) Score
The mRS scale is used to assess neurological status. mRS scale ranges from 0 (no residual symptoms) to 6 (dead). Higher scores indicate greater disability.
36-Item Short Form Health Survey (SF-36) score
The SF-36 questionnaire is a health-related quality of life scale, comprising eight scaled scores: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. Scores range from 0 - 100. Higher scores mean less disability.
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Assistance Publique - Hôpitaux de Paris
Lead sponsor
ORIXHA
Collaborator
