iCOOL 1 (Induction of COOLing 1): A Randomized Trial Comparing 2 Methods for Rapid Induction of Cooling in Stroke Patients, Cold Infusions vs. RhinoChill
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Brain temperature
研究概览
简要总结
Mild hypothermia improves outcome in patients with global cerebral ischemia after cardiac arrest. Hypothermia seems promising also in other acute hypoxic-ischemic or in brain swelling associated cerebrovascular disease. The narrow-time-frame is a major issue ("time is brain"). To provide immediate cooling without delay, easy to use, mobile and effective methods are needed. Cold infusions (4 °C) are an accepted standard worldwide. The RhinoChill (BeneChill, USA) is a new device. A comparison of these two induction methods has never been done before. Neither was the effect of cold infusions on brain-temperature measured. For the first time iCOOL 1 compares feasibility, safety and efficacy of the two methods.
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
- None
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
- •Sedation, intubation and mechanical ventilation
- •Combined ICP-temperature-probe
- •Indication to lower body temperature
- •Age ≥ 18 years
排除标准
- •Body weight > 120 kg
- •Fever > 38.5°C
- •Chronic sinusitis
- •Current or past fracture or surgery of the paranasal sinuses
- •Severe infection with bacteremia or sepsis ≤ 72 h
- •Severe renal insufficiency
- •Severe liver insufficiency
- •Acute pulmonary embolism
- •Acute myocardial infarction
- •Severe cardiac insufficiency (NYHA ≥ III)
- •Threatening ventricular dysrhythmia
- •Cardiac dysrhythmia with bradycardia (heart rate < 50 /min, QTc > 450 ms, sick sinus syndrome, AV-block II-III°).
- •Known hematologic disease with increased risk of thrombosis (e.g. cryoglobulinemia, cold agglutinins, sickle cell anemia)
- •Known vasospastic vascular disorder (e.g. Raynaud's phenomenon or thromboangiitis obliterans)
研究组 & 干预措施
Cold infusions
Infusion of 2L cold crystalloid solution (4°C) over 30 minutes
干预措施: Cold crystalloid infusions, 0.9%NaCl or Ringer's solution (Drug)
RhinoChill
Nasopharyngeal cooling with the RhinoChill device (BeneChill, USA)
干预措施: RhinoChill (Device)
结局指标
主要结局
Brain temperature
时间窗: -15 to +60min
Primary endpoint: Change of brain temperature during one hour after start of cooling. Repeated measurement ANOVA for within subject contrasts (phase 1 (0 to 15min), 2 (15 to 30min), 3 (30 to 45min) and 4 (45 to 60min)) vs. baseline (-15 to 0min)
次要结局
- (Neuro-)vital parameters(-15 to +60 min)
- Cerebral autoregulation(-15 to +60 min)
- Safety(0-6 months)
研究者
Dr. Sven Poli
Consultant Neurologist, Principal Investigator
University Hospital Heidelberg