PRE-hospital Cooling to improvE carDiac arrEst Neurological outComEs (PRECEDENCE)
NCT07421882
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
Inclusion Criteria: 1. Out-of-hospital cardiac arrest (OHCA) of any rhythm attended by Singapore Civil Defence Force (SCDF) paramedics. 2. Return of spontaneous circulation (ROSC) achieved in the pre-hospital setting. 3. Age ≥16 years and ≤80 years. 4. Patient remains comatose after ROSC, with Glasgow Coma Scale (GCS) ≤8. Exclusion Criteria: 1. Age \>80 years. 2. Traumatic cause of cardiac arrest. 3. Tympanic temperature \<34°C at time of assessment. 4. Pregnant females. 5. Termination of resuscitation in the Emergency Department. 6. Withdrawal of life support within 24 hours of Coronary Care Unit (CCU) admission.
Conditions5
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NCT07421882