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

• Status: Unknown status
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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. EMCOOLS Flex.Pads (Emergency Medical Cooling Systems AG, Wien, Austria) is a new non-invasive surface cooling system. A comparison of these two induction methods has never been done before. Neither was the effect of EMCOOLS Flex.Pads on brain-temperature measured. For the first time iCOOL 2 compares feasibility, safety and efficacy of the two methods.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Heidelberg
• Treatments: Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Sedation

• Combined ICP-temperature-probe

• Indication to lower body temperature > 1.5°C

• Age ≥ 18 years

Exclusion Criteria:

• Body weight > 120 kg

• Severe renal insufficiency

• Acute pulmonary embolism

• Acute myocardial infarction

• High-grade heart valve stenosis or insufficiency

• Severe cardiac insufficiency (NYHA ≥ III)

• Threatening ventricular dysrhythmia

• Cardiac dysrhythmia with bradycardia (heart rate < 45 /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)

• Skin lesions not allowing a secure application of the EMCOOLS Flex.Pads