A Phase 2 interventional study of RhinoChill and Cold crystalloid infusions, 0.9%NaCl or Ringer's solution in Ischemic Stroke and Hemorrhagic Stroke, sponsored by University Hospital Heidelberg. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-04-26.
Sponsored by University Hospital Heidelberg · Phase 2, Interventional, and Treatment
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 20 is below the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →University Hospital Heidelberg is the lead sponsor of 175 studies on the registry; 48 are open to participants now.
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Exclusion Criteria:
Infusion of 2L cold crystalloid solution (4°C) over 30 minutes
Drug: Cold crystalloid infusions, 0.9%NaCl or Ringer's solution
Nasopharyngeal cooling with the RhinoChill device (BeneChill, USA)
Device: RhinoChill
Nasopharyngeal cooling with the RhinoChill device
Also known as: BeneChill, USA
Infusion of 2L cold crystalloid solution (4°C) over 30 minutes
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
This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.
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University Hospital Heidelberg