A Randomized Trial Comparing 2 Methods for Rapid Induction of Cooling in Stroke Patients, Cold Infusions vs. RhinoChill (iCOOL 1)

Study Overview
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Brief Summary
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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.

Official Title
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iCOOL 1 (Induction of COOLing 1): A Randomized Trial Comparing 2 Methods for Rapid Induction of Cooling in Stroke Patients, Cold Infusions vs. RhinoChill

Conditions
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Ischemic Stroke, Hemorrhagic Stroke

Intervention / Treatment
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* Device: RhinoChill
* Drug: Cold crystalloid infusions, 0.9%NaCl or Ringer's solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sedation, intubation and mechanical ventilation Combined ICP-temperature-probe Indication to lower body temperature Age ≥ 18 years Exclusion Criteria: Body weight > 120 kg Fever > 38.5°C Chronic sinusitis Current or past fracture or surgery of the paranasal sinuses Severe infection with bacteremia or sepsis ≤ 72 h Severe renal insufficiency Severe liver insufficiency Acute pulmonary embolism Acute myocardial infarction Severe cardiac insufficiency (NYHA ≥ III) Threatening ventricular dysrhythmia Cardiac dysrhythmia with bradycardia (heart rate < 50 /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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cold infusions<br>Infusion of 2L cold crystalloid solution (4°C) over 30 minutes | Drug: Cold crystalloid infusions, 0.9%NaCl or Ringer's solution<br>* Infusion of 2L cold crystalloid solution (4°C) over 30 minutes<br>|
| Active Comparator: RhinoChill<br>Nasopharyngeal cooling with the RhinoChill device (BeneChill, USA) | Device: RhinoChill<br>* Nasopharyngeal cooling with the RhinoChill device<br>* Other names: BeneChill, USA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | -15 to +60min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| (Neuro-)vital parameters | Effects on (neuro-)vital parameters (e.g. HR, AP, ICP, CPP) are registered. | -15 to +60 min | 
| Cerebral autoregulation | Cerebral auto-regulation parameters (e.g. PRx) are calculated on the basis of the (neuro-)vital parameters monitored. | -15 to +60 min | 
| Safety | Various safety parameters, such as bleeding complications, cardiac decompensation, or local irritations in the nasopharynx are assessed. | 0-6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypothermia, induction of hypothermia, cold infusion, nasopharyngeal cooling, stroke, intracranial hemorrhage, cerebrovascular disease, neuro intensive care