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

University Hospital Heidelberg20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ischemic Stroke Hemorrhagic Stroke

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Brain temperature

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)

Time frame: -15 to +60min

Secondary Outcomes

(Neuro-)vital parameters

Effects on (neuro-)vital parameters (e.g. HR, AP, ICP, CPP) are registered

Time frame: -15 to +180 min

Cerebral autoregulation

Cerebral auto-regulation parameters (e.g. PRx) are calculated on the basis of the (neuro-)vital parameters monitored.

Time frame: 15 to +180 min

Safety

Various safety parameters, such as bleeding complications, cardiac decompensation, or local skin irritations are assessed.

Time frame: 0 - 7 days