Long-term follow-up of cardiac arrest survivors treated with ultra-rapid cooling
Long Term Follow-up of Cardiac Arrest Survivors Exposed to Ultra-rapid Cooling, a Prospective Non-interventional Cohort
This follow-up will see if people who survived cardiac arrest after ultra-rapid cooling with Vent2Cool have better long-term function and quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 2 sites (Angers and 1 other locations) |
| Trial ID | NCT07028372 on ClinicalTrials.gov |
What this trial studies
This is an observational long-term follow-up of adults who were enrolled in the OverCool investigation and received ultra-rapid cooling with the Vent2Cool system, with inclusion limited to those alive 28 days after cardiac arrest. Data collection includes patient-reported outcomes and functional measures such as the SF-36, modified Rankin Score, ADL questionnaire, NYHA class, and SGRQ, obtained with non-opposition/consent within three months after the parent study. The study is conducted at participating French centers (Angers University Hospital and AP-HP Cochin Hospital) and documents morbidity, mortality, and quality-of-life trajectories after post-cardiac arrest syndrome. The aim is to characterize long-term safety, functional recovery, and respiratory and cardiac status following ultra-rapid hypothermia induction by total liquid ventilation.
Who should consider this trial
Good fit: Adults (18+) who were included in the OverCool investigation, received the Vent2Cool procedure, and were alive 28 days after cardiac arrest with no opposition to follow-up.
Not a fit: Patients who were included but did not receive the Vent2Cool procedure, those who refuse follow-up, or those who cannot be reached are not eligible and will not benefit from this follow-up.
Why it matters
Potential benefit: If successful, this follow-up could show that ultra-rapid cooling reduces long-term neurological and cardiac complications and improves survivors' quality of life.
How similar studies have performed: External targeted temperature management trials have shown mixed results, while animal studies and limited human data suggest earlier cooling is beneficial; hypothermic total liquid ventilation (Vent2Cool) is a novel approach with limited clinical experience to date.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Angers and 1 other locations
- Angers University Hospital, Medical Intensive Care Unit, Vent'Lab — Angers, France (Not_yet_recruiting)
- AP-HP Centre, Cochin Hospital, Medical Intensive Care Unit — Paris, France (Recruiting)
Study contacts
- Principal investigator: Alain CARIOU, MD PhD — AP-HP, Cochin Hospital, Intensive Care and Resuscitation Department
- Study coordinator: Alain CARIOU, MD PhD
- Email: alain.cariou@aphp.fr
- Phone: +33 1 58 41 25 01
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.