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. The RhinoChill (BeneChill, USA) is a new device. A comparison of these two induction methods has never been done before. Neither was the effect of cold infusions on brain-temperature measured. For the first time iCOOL 1 compares feasibility, safety and efficacy of the two methods.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Nasopharyngeal cooling with the RhinoChill device
Infusion of 2L cold crystalloid solution (4°C) over 30 minutes
Neuro Intensive Care Unit 2, Dept. of Neurology, University Hospital Heidelberg
Heidelberg, Germany
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
(Neuro-)vital parameters
Effects on (neuro-)vital parameters (e.g. HR, AP, ICP, CPP) are registered.
Time frame: -15 to +60 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 +60 min
Safety
Various safety parameters, such as bleeding complications, cardiac decompensation, or local irritations in the nasopharynx are assessed.
Time frame: 0-6 months
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