A Randomized Trial Comparing 2 Methods for Rapid Induction of Cooling in Stroke Patients, Cold Infusions vs. RhinoChill (iCOOL 1)

iCOOL 1 (Induction of COOLing 1): A Randomized Trial Comparing 2 Methods for Rapid Induction of Cooling in Stroke Patients, Cold Infusions vs. RhinoChill

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.

Inclusion Criteria:

• Sedation, intubation and mechanical ventilation
• Combined ICP-temperature-probe
• Indication to lower body temperature
• Age ≥ 18 years

Exclusion Criteria:

• 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)