Pre-hospital wearable cooling after out-of-hospital cardiac arrest

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

This pilot test tries a battery-free CarbonCool® cooling vest applied by paramedics to adults who regain a pulse after out-of-hospital cardiac arrest but remain unconscious to see if early cooling is feasible and safe.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 16 Years to 80 Years
• Sex: All
• Sponsor: Singapore General Hospital (Academic / other)
• Locations: 1 site (Singapore)
• Trial ID: NCT07421882 on ClinicalTrials.gov

What this trial studies

PRECEDENCE is a pilot feasibility trial led by Singapore General Hospital and the Singapore Civil Defence Force that tests initiating targeted temperature management in the field using a power-free CarbonCool® surface cooling vest after return of spontaneous circulation (ROSC). Eligible adult OHCA patients attended by SCDF paramedics who remain comatose after ROSC are allocated to pre-hospital cooling with the vest or to standard pre-hospital care based on predefined operational criteria. The trial measures feasibility, protocol fidelity, EMS provider acceptability, and safety, and follows participants through hospital admission to discharge. Findings will inform the design of a larger definitive trial to determine whether very early cooling improves neurological outcomes.

Who should consider this trial

Good fit: Adults aged 16–80 who suffer out-of-hospital cardiac arrest, achieve ROSC in the field, and remain comatose (GCS ≤8) when attended by SCDF Division 4 paramedics are the intended candidates.

Not a fit: Patients with traumatic arrest, core temperature under 34°C, pregnancy, age over 80, or those with early withdrawal/termination of care are excluded and would not be expected to benefit from this intervention.

Why it matters

Potential benefit: If successful, earlier cooling started by EMS could reduce brain injury and increase the chance of better neurological recovery after out-of-hospital cardiac arrest.

How similar studies have performed: Prior pre-hospital cooling approaches (for example, cold IV fluids) have produced mixed results and some safety concerns, so this novel power-free surface-vest approach remains relatively untested in real-world EMS settings.

Eligibility criteria

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.

Where this trial is running

Singapore

• National University Heart Centre, Singapore (NUHCS) — Singapore, Singapore (Recruiting)

Study contacts

• Study coordinator: Shir Lynn Lim, MBBS

Conditions Out-Of-Hospital Cardiac Arrest; Cardiopulmonary Resuscitation; Death, Sudden, Cardiac; Therapeutic Hypothermia; Return of Spontaneous Circulation