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

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.

Conditions

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

Interventions

OTHER

Short 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.

OTHER

Modified 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.

OTHER

Activity 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.

OTHER

New 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.

OTHER

St 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.

Sponsors & Collaborators

• ORIXHA

  collaborator INDUSTRY

• Assistance Publique - Hôpitaux de Paris

  lead OTHER

Principal Investigators

• Alain CARIOU, MD PhD · AP-HP, Cochin Hospital, Intensive Care and Resuscitation Department

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-06-11

Primary Completion

2031-12-31

Completion

2031-12-31

Countries

• France

Study Locations