Overview

A Randomized Trial Comparing 2 Methods for Rapid Induction of Cooling in Stroke Patients, Cold Infusions vs. EMCOOLS Brain.Pad (iCOOL 3)

Status:
Completed
Trial end date:
2012-05-01
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 Brain.Pad (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 the EMCOOLS Brain.Pad on brain-temperature measured. For the first time iCOOL 3 compares feasibility, safety and efficacy of the two methods.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University Hospital Heidelberg
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 Brain.Pad