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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 16
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Singapore
National University Heart Centre, Singapore (NUHCS)
RECRUITING
Singapore
Contact Information
Primary
Shir Lynn Lim, MBBS
shir.lynn.lim@nus.edu.sg
+65 91760383
Time Frame
Start Date: 2026-02-01
Estimated Completion Date: 2027-03
Participants
Target number of participants: 50
Treatments
Experimental: Pre-hospital Targeted Temperature Management
Eligible out-of-hospital cardiac arrest (OHCA) patients who achieve return of spontaneous circulation (ROSC) and meet inclusion criteria will receive early targeted temperature management (TTM) initiated in the pre-hospital setting by Singapore Civil Defence Force (SCDF) paramedics. Cooling is delivered using the CarbonCool® surface cooling vest, applied immediately after ROSC and maintained during transport to the receiving hospital. Upon hospital arrival, a 1-for-1 vest exchange is performed in the Emergency Department before continuation of standard post-cardiac arrest care.
Related Therapeutic Areas
Sponsors
Leads: Singapore General Hospital
Collaborators: Singapore Civil Defence Force, National University Heart Centre, Singapore

This content was sourced from clinicaltrials.gov