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.
Study 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
Sex
ALL
Min age
16 Years
Max age
80 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Recruitment feasibility — Through study completion, anticipated to be one year Proportion of EMS-attended, eligible OHCA patients who received pre-hospital TTM
Intervention feasibility — Through study completion, anticipated to be one year Proportion of recruited OHCA patients receiving the TTM protocol as intended
Proportion of cases with complete adherence of workflow and case report forms — Through study completion, anticipated to be one year Adherence of paramedics to workflow and case report forms
Acceptability of Intervention Measure (AIM) — Time frame within 3 months of case recruitment 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.
Intervention Appropriateness Measure (IAM) — Time frame within 3 months of case recruitment Perceived appropriateness of the intervention will be evaluated using the validated Intervention Appropriateness Measure (IAM). The IAM is a 4-item questionnaire rated on a 5-point Likert scale, with higher scores indicating greater perceived fit and relevance of the intervention for prehospital care. Range score between 4 to 20.
Feasibility of Intervention Measure (FIM) scores — Time frame within 3 months of case recruitment Feasibility of implementing the intervention in the operational prehospital setting will be assessed using the validated Feasibility of Intervention Measure (FIM). The FIM comprises 4 items rated on a 5-point Likert scale, with higher scores indicating greater perceived feasibility. Range score between 4 to 20.
Trial sites (1)
Facility
City
Region
Status
National University Heart Centre, Singapore (NUHCS)
Singapore
Singapore
Recruiting
More Singapore General Hospital trials in Singapore
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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