NCT07421882

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Singapore General Hospital · Academic / Other
• Sex: All
• Age: 16 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Background: Despite advances in resuscitation, neurological recovery after out-of-hospital cardiac arrest (OHCA) remains poor. Current hospital-initiated targeted temperature management (TTM) often begins several hours after ROSC, potentially missing the optimal neuroprotective window. Early or ultra-early cooling during the pre-hospital phase may mitigate ischemia-reperfusion brain injury, but evidence from real-world EMS settings is limited. Rationale: The PRECEDENCE study tests the operational feasibility of initiating TTM in the pre-hospital environment using a novel, power-free CarbonCool® cooling vest designed for rapid application by paramedics immediately after ROSC. The vest provides conductive surface cooling without interfering with resuscitation, transport, or diagnostics. Study Design: PRECEDENCE is a pilot feasibility trial conducted by the Singapore Civil Defence Force (SCDF) and collaborating hospital. Eligible OHCA patients attended by SCDF Division 4 paramedics will be allocated to either (a) pre-hospital TTM using the CarbonCool® vest or (b) standard pre-hospital care, depending on predefined eligibility and operational criteria. Both groups will be prospectively followed through hospital discharge. Outcomes: The primary outcome is feasibility of implementing pre-hospital TTM, evaluated through recruitment rates, intervention delivery, protocol fidelity, and provider acceptability. Secondary outcomes include hospital TTM uptake, time from ROSC to target temperature, neurological outcome at discharge (CPC 1-2), and predefined safety endpoints (overshoot cooling \< 33 °C, hemodynamically significant bradyarrhythmias, and skin injury). Significance: By assessing real-world feasibility and safety of early pre-hospital cooling, this pilot will provide critical implementation data and guide protocol refinements for a future multi-division or national randomized trial.

Conditions

• Out-Of-Hospital Cardiac Arrest
• Cardiopulmonary Resuscitation
• Death, Sudden, Cardiac
• Therapeutic Hypothermia

Interventions

Type	Name	Description
DEVICE	CarbonCool® 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.

Timeline

• Start date: 2026-02-01
• Primary completion: 2026-12-01
• Completion: 2027-03-01
• First posted: 2026-02-19
• Last updated: 2026-02-24

Locations

1 site across 1 country: Singapore