Hemorrhagic Stroke, Ischemic Stroke
Conditions
Keywords
hypothermia, induction of hypothermia, cold infusion, whole-body cooling, external cooling, surface cooling, non invasive cooling, stroke, intracranial hemorrhage, cerebrovascular disease, neuro intensive care
Brief 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.
Interventions
Infusion of 2L cold crystalloid solution (4°C) over 30 minutes
DEVICEEMCOOLS Flex.Pads
Passive whole-body surface cooling with 10 EMCOOLS Flex.Pads
Sponsors
University Hospital Heidelberg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brain temperature | -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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| (Neuro-)vital parameters | -15 to +180 min | Effects on (neuro-)vital parameters (e.g. HR, AP, ICP, CPP) are registered |
| Cerebral autoregulation | 15 to +180 min | Cerebral auto-regulation parameters (e.g. PRx) are calculated on the basis of the (neuro-)vital parameters monitored. |
| Safety | 0 - 7 days | Various safety parameters, such as bleeding complications, cardiac decompensation, or local skin irritations are assessed. |
Countries
Germany
Contacts
Primary ContactSven Poli, Dr. med.
Outcome results
None listed