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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-80
SponsorSingapore General Hospital

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

Age >80 years.

Traumatic cause of cardiac arrest.

Tympanic temperature <34°C at time of assessment.

Pregnant females.

Trial design

Treatments tested in this trial

  • CarbonCool® Cooling Vest

Treatment groups

50 Participants
are divided into 1 treatment group

Sponsors and collaborators

Singapore General Hospital

Lead sponsor

Singapore Civil Defence Force

Collaborator

National University Heart Centre, Singapore

Collaborator