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

April 23, 2026 updated by: Singapore General Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Background: Despite advances in resuscitation, neurological recovery after out-of-hospital cardiac arrest (OHCA) remains poor. Current hospital-initiated targeted temperature management (TTM) often begins several hours after ROSC, potentially missing the optimal neuroprotective window. Early or ultra-early cooling during the pre-hospital phase may mitigate ischemia-reperfusion brain injury, but evidence from real-world EMS settings is limited.

Rationale: The PRECEDENCE study tests the operational feasibility of initiating TTM in the pre-hospital environment using a novel, power-free CarbonCool® cooling vest designed for rapid application by paramedics immediately after ROSC. The vest provides conductive surface cooling without interfering with resuscitation, transport, or diagnostics.

Study Design: PRECEDENCE is a pilot feasibility trial conducted by the Singapore Civil Defence Force (SCDF) and collaborating hospital. Eligible OHCA patients attended by SCDF Division 4 paramedics will be allocated to either (a) pre-hospital TTM using the CarbonCool® vest or (b) standard pre-hospital care, depending on predefined eligibility and operational criteria. Both groups will be prospectively followed through hospital discharge.

Outcomes: The primary outcome is feasibility of implementing pre-hospital TTM, evaluated through recruitment rates, intervention delivery, protocol fidelity, and provider acceptability. Secondary outcomes include hospital TTM uptake, time from ROSC to target temperature, neurological outcome at discharge (CPC 1-2), and predefined safety endpoints (overshoot cooling < 33 °C, hemodynamically significant bradyarrhythmias, and skin injury).

Significance: By assessing real-world feasibility and safety of early pre-hospital cooling, this pilot will provide critical implementation data and guide protocol refinements for a future multi-division or national randomized trial.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Singapore
      • Singapore, Singapore, 119074
        • Recruiting
        • National University Heart Centre, Singapore (NUHCS)
        • Contact:
        • Principal Investigator:
          • Shir Lynn Lim, MBBS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment feasibility
Time Frame: Through study completion, anticipated to be one year
Proportion of EMS-attended, eligible OHCA patients who received pre-hospital TTM
Through study completion, anticipated to be one year
Intervention feasibility
Time Frame: Through study completion, anticipated to be one year
Proportion of recruited OHCA patients receiving the TTM protocol as intended
Through study completion, anticipated to be one year
Proportion of cases with complete adherence of workflow and case report forms
Time Frame: Through study completion, anticipated to be one year
Adherence of paramedics to workflow and case report forms
Through study completion, anticipated to be one year
Acceptability of Intervention Measure (AIM)
Time Frame: 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.
Time frame within 3 months of case recruitment
Intervention Appropriateness Measure (IAM)
Time Frame: 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.
Time frame within 3 months of case recruitment
Feasibility of Intervention Measure (FIM) scores
Time Frame: 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.
Time frame within 3 months of case recruitment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Eligible OHCA Patients Receiving Hospital TTM
Time Frame: 6 hours
Percentage of out-of-hospital cardiac arrest (OHCA) patients who meet inclusion criteria and subsequently receive targeted temperature management (TTM) in hospital.
6 hours
Time to Achieve Target Core Temperature After ROSC
Time Frame: 12 hours
Duration (in minutes) from return of spontaneous circulation (ROSC) to achievement of target core temperature
12 hours
Good Neurological Outcome at Hospital Discharge
Time Frame: To hospital discharge, with an average of 30 days
Proportion of patients with a Cerebral Performance Category (CPC) score of 1 or 2 at hospital discharge.
To hospital discharge, with an average of 30 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Overshoot Cooling (<33°C)
Time Frame: 72 hours
Number and proportion of patients with a core temperature drop below 33°C during surface cooling in the Coronary Care Unit (CCU).
72 hours
Incidence of Hemodynamically Significant Bradyarrhythmias
Time Frame: 72 hours
Number and proportion of patients experiencing clinically significant bradyarrhythmias (requiring intervention or causing hemodynamic instability).
72 hours
Incidence of Skin Injury Related to Cooling Device
Time Frame: 72 hours
Number and proportion of patients with skin injury (e.g., erythema, blister, burn) attributed to use of the surface cooling device.
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Singapore General Hospital

Collaborators

National University Heart Centre, Singapore
Singapore Civil Defence Force

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

December 1, 2025

First Submitted That Met QC Criteria

February 11, 2026

First Posted (Actual)

February 19, 2026

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRECEDENCE 1.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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