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

Completed

Phase 2 Results N/A

Eligibility Criteria

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)