PRE-hospital Cooling to improvE carDiac arrEst Neurological outComEs (PRECEDENCE)
NCT07421882 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2026-04-29
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.
Conditions
- Out-Of-Hospital Cardiac Arrest
- Cardiopulmonary Resuscitation
- Death, Sudden, Cardiac
- Therapeutic Hypothermia
Interventions
- 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.
Sponsors & Collaborators
-
Singapore Civil Defence Force
collaborator OTHER -
National University Heart Centre, Singapore
collaborator OTHER -
Singapore General Hospital
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 16 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-02-01
- Primary Completion
- 2026-12-31
- Completion
- 2027-03-31
Countries
- Singapore
Study Locations
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