PRE-hospital Cooling to improvE carDiac arrEst Neurological outComEs (PRECEDENCE): a Pilot Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Recruitment feasibility
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This is an open-label study. Masking of participants, care providers, and outcome assessors is not feasible due to the visible and operational nature of the cooling intervention in the pre-hospital environment. All analyses will be performed by the research team using de-identified data to minimize potential assessment bias.
入排标准
- 年龄范围
- 16 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: CarbonCool® Cooling Vest (Device)
结局指标
主要结局
Recruitment feasibility
时间窗: Through study completion, anticipated to be one year
Proportion of EMS-attended, eligible OHCA patients who received pre-hospital TTM
Intervention feasibility
时间窗: 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
时间窗: Through study completion, anticipated to be one year
Adherence of paramedics to workflow and case report forms
Acceptability of Intervention Measure (AIM)
时间窗: 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)
时间窗: 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
时间窗: 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.
次要结局
- Proportion of Eligible OHCA Patients Receiving Hospital TTM(6 hours)
- Time to Achieve Target Core Temperature After ROSC(12 hours)
- Good Neurological Outcome at Hospital Discharge(To hospital discharge, with an average of 30 days)