RecruitingNCT07028372

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

Long Term Follow-up of Cardiac Arrest Survivors Exposed to Ultra-rapid Cooling, a Prospective Non-interventional Cohort

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

12 participants

Start Date

Jun 11, 2025

Study Type

OBSERVATIONAL

Conditions

Cardiac Arrest (CA)Resuscitated Sudden Cardiac Death Post Cardiac Arrest Patient Who Was Treated by Hypothermia Protocol

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

Min Age: 18 Years

Inclusion Criteria3

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 Criteria3

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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Interventions

OTHERShort Form Health Survey (SF-36)

Heath-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.

OTHERModified Rankin Score (mRS)

The 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.

OTHERActivity of Daily Living (ADL) questionnaire

Level 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.

OTHERNew York Heart Association (NYHA) Classification

The 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.

OTHERSt George's Respiratory Questionnaire (SGRQ)

Respiratory 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.