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NCT Number: NCT07421882

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

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.

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Key information

Age range

16 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National University Heart Centre, Singapore (NUHCS)

Singapore, 119074

Location status: Recruiting

Location contact

Kai Lee Woo

CONTACT

[email protected]

+6584136810

Shir Lynn Lim, MBBS

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Age >80 years.
  • Traumatic cause of cardiac arrest.
  • Tympanic temperature <34°C at time of assessment.
  • Pregnant females.
  • Termination of resuscitation in the Emergency Department.
  • Withdrawal of life support within 24 hours of Coronary Care Unit (CCU) admission.

Treatment and study plan

CarbonCool® Cooling Vest

Device

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.

Primary outcomes

  1. Recruitment feasibility

    Time frame: Through study completion, anticipated to be one year

    Proportion of EMS-attended, eligible OHCA patients who received pre-hospital TTM

  2. Intervention feasibility

    Time frame: Through study completion, anticipated to be one year

    Proportion of recruited OHCA patients receiving the TTM protocol as intended

  3. 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

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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.

Other outcomes

  1. 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).

  2. Incidence of Hemodynamically Significant Bradyarrhythmias

    Time frame: 72 hours

    Number and proportion of patients experiencing clinically significant bradyarrhythmias (requiring intervention or causing hemodynamic instability).

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Shir Lynn Lim, MBBS

CONTACT

[email protected]

+65 91760383

Sponsors and collaborators

Lead sponsor

Singapore General Hospital

Other

Collaborators

  • National University Heart Centre, Singapore
  • Singapore Civil Defence Force

Registry information

Official study title

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

Acronym: PRECEDENCE

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Feb 19, 2026
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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