Prehospital Cooling of Comatose Patients After Cardiac Arrest With a Non-invasive, Unpowered Core Body Cooling Device (CAERVest Prehospital Cooling)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Cooling rate
研究概览
简要总结
Single centre randomized controlled two arm clinical trial of patients after out of hospital cardiac arrest with return of spontaneous circulation.
The trial objective is to investigate external cooling of cardiac arrest patients after cardiac arrest with the CAERvest cooling device.
After checking inclusion and exclusion criteria and immediately after return of spontaneous circulation, the CAERvest device will be filled and placed on the supine patient's chest. A recording oesophageal temperature probe will be inserted and connected to the defibrillator. Then the patient will be transported to the Emergency Department.
After admission to the emergency department, an additional endovascular cooling device will be placed and the patient will be cooled to 33°C for 24 hours (starting after reaching the target temperature range of under 34°C) with the endovascular cooling device.
Then the patient will be rewarmed at 0.25 °C/h. The CAERvest device will be removed, when a temperature below 34°C is reached.
After rewarming, the temperature will be controlled to be below 37.5°C for until 48 hours after cardiac arrest. After this time point pyrexia (core temperature above 37.5°C) will be treated with common pharmaceutical measures. Sedation, analgesia and relaxation will be discontinued at 36.5°C. Neurologic evaluation will be started not before 72 hours after cardiac arrest with a predefined evaluation protocol. During follow up the following secondary outcomes will be recorded: Survival to hospital discharge, survival to 30 days, survival to 6 months, best neurologic function within 30 days, best neurologic function within 6 months, and quality of life at 6 months.
详细描述
1 CLINICAL TRIAL PLAN 1.1 Trial Objective The objective of this outcome clinical trial is to evaluate the effectiveness and safety of ultra-early therapeutic hypothermia in cardiac arrest patients using the CAERvest® device.
1.2 Trial Design This clinical trial is a single centre randomized controlled two arm clinical trial. Randomization will be in a 1:1 ratio. The patients will be randomized to a Test Arm (OOH-Cooling; prehospital and in-hospital cooling) or to a Control Arm (Control-Cooling; in-hospital cooling only). The study will include up to 80 patients (40 subjects in each arm).
1.3 Patient Population Subjects will include out of hospital cardiac arrest patients with return of spontaneous circulation, who meet the trial eligibility requirements.
1.4 Clinical Trial Procedures 1.4.1 Patient Screening Patient screening will be conducted by emergency physicians of the emergency medical system (EMS) system of Vienna by help of the Field Supervisor System of the EMS. All out of hospital cardiac arrest, patients with return of spontaneous circulation will be evaluated for inclusion into the trial. The subject's eligibility for the study will be evaluated based on the criteria outlined above in the inclusion/exclusion criteria section.
Enrollment becomes official once eligible subjects meet inclusion/exclusion criteria and the patient is randomized to either Test or Control Arm of the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Patient will be comatose on inclusion. Outcome assessor will not be aware of group assignment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 18 years of age
- •Witnessed cardiac arrest
- •Restoration of spontaneous circulation
- •All Primary rhythms
- •Cardiac arrest of presumed cardiac origin
排除标准
- •Hypothermia (< 34 °C) on screening
- •Comatose prior to cardiac arrest due to central nervous system depressant drugs
- •CPC higher than 2 prior to cardiac arrest
- •Known pregnancy
- •Glasgow coma scale (GCS) > 8 at screening
- •Known malignancy e.g. terminal illness (pre-cardiac arrest life expectancy of < 6 months due to underlying medical conditions or pre-existing co-morbidities.)
- •Follow up unlikely to be possible
- •Patients already randomized to a clinical trial
- •The patient has a known history of bleeding diathesis, coagulopathy, cryoglobulinemia, sickle cell anaemia, or will refuse blood transfusions
- •The patient is a vulnerable subject, for instance, a person in detention (i.e., prisoner or ward of the state)
结局指标
主要结局
Cooling rate
时间窗: 4 hours
Significant reduction of oesophageal temperature with the CAERvest cooling device compared to the control group at start of the endovascular cooling device, calculated as the difference in core temperature at start of second cooling device and initial core temperature by time.
次要结局
- Survival to 6 months(6 months)
- Earlier achievement of target temperature(4 hours)
- Ease of use and operator experience with the cooling device(4 hours)
- Survival to hospital discharge(14 days)
- Survival to 30 days(30 days)
- Best neurologic function within 30 days(30 days)
- Best neurologic function within 6 months(6 months)
- Quality of life at 6 months(6 months)
研究者
Michael Holzer
Clinical Professor
Medical University of Vienna