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.
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.
Age >80 years.
Traumatic cause of cardiac arrest.
Tympanic temperature <34°C at time of assessment.
Pregnant females.
Single group
CarbonCool® Cooling Vest
DeviceThe 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.
Recruitment feasibility
Proportion of EMS-attended, eligible OHCA patients who received pre-hospital TTM
Intervention feasibility
Proportion of recruited OHCA patients receiving the TTM protocol as intended
Proportion of cases with complete adherence of workflow and case report forms
Adherence of paramedics to workflow and case report forms
Acceptability of Intervention Measure (AIM)
Paramedic acceptability of the intervention will be assessed using the validated Acceptability of Intervention Measure (AIM). The AIM consists of a 4-item questionnaire rated on a 5-point Likert scale, with higher scores indicating greater acceptability of the intervention. Range score between 4 to 20.
Proportion of Eligible OHCA Patients Receiving Hospital TTM
Percentage of out-of-hospital cardiac arrest (OHCA) patients who meet inclusion criteria and subsequently receive targeted temperature management (TTM) in hospital.
Time to Achieve Target Core Temperature After ROSC
Duration (in minutes) from return of spontaneous circulation (ROSC) to achievement of target core temperature
Good Neurological Outcome at Hospital Discharge
Proportion of patients with a Cerebral Performance Category (CPC) score of 1 or 2 at hospital discharge.
Incidence of Overshoot Cooling (<33°C)
Number and proportion of patients with a core temperature drop below 33°C during surface cooling in the Coronary Care Unit (CCU).
Incidence of Hemodynamically Significant Bradyarrhythmias
Number and proportion of patients experiencing clinically significant bradyarrhythmias (requiring intervention or causing hemodynamic instability).
Incidence of Skin Injury Related to Cooling Device
Number and proportion of patients with skin injury (e.g., erythema, blister, burn) attributed to use of the surface cooling device.
Click on the lead sponsor to view all of their trials.
Singapore General Hospital
Lead sponsor
Singapore Civil Defence Force
Collaborator
National University Heart Centre, Singapore
Collaborator
