RecruitingNot ApplicableNCT07421882

PRE-hospital Cooling to improvE carDiac arrEst Neurological outComEs (PRECEDENCE)

PRE-hospital Cooling to improvE carDiac arrEst Neurological outComEs (PRECEDENCE): a Pilot Feasibility Study

Sponsor

Singapore General Hospital

Enrollment

50 participants

Start Date

Feb 1, 2026

Study Type

INTERVENTIONAL

Conditions

Cardiopulmonary Resuscitation Death, Sudden, Cardiac Out-of-hospital cardiac arrest Therapeutic Hypothermia

Summary

The PRE-hospital Cooling to improvE carDiac arrEst Neurological outComEs (PRECEDENCE) study is a pilot feasibility trial evaluating the implementation of pre-hospital targeted temperature management (TTM) using a wearable surface cooling device (CarbonCool® vest) in adult out-of-hospital cardiac arrest (OHCA) patients with return of spontaneous circulation (ROSC). The study aims to assess feasibility, fidelity, acceptability, and safety of initiating cooling in the field by emergency medical services (EMS) prior to hospital arrival. Results will inform the design of a larger definitive trial to determine the clinical effectiveness of early pre-hospital TTM in improving neurological outcomes.

Eligibility

Min Age: 16 YearsMax Age: 80 Years

Inclusion Criteria4

Out-of-hospital cardiac arrest (OHCA) of any rhythm attended by Singapore Civil Defence Force (SCDF) paramedics.
Return of spontaneous circulation (ROSC) achieved in the pre-hospital setting.
Age ≥16 years and ≤80 years.
Patient remains comatose after ROSC, with Glasgow Coma Scale (GCS) ≤8.

Exclusion Criteria6

Age >80 years.
Traumatic cause of cardiac arrest.
Tympanic temperature <34°C at time of assessment.
Pregnant females.
Termination of resuscitation in the Emergency Department.
Withdrawal of life support within 24 hours of Coronary Care Unit (CCU) admission.

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Interventions

DEVICECarbonCool® Cooling Vest

The CarbonCool® vest is a power-free, thermoplastic polyurethane (TPU) surface cooling device containing a proprietary carbon-based cooling medium capable of high heat exchange (35 W/mK). It is designed for rapid pre-hospital application and continuous cooling during patient transport.