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

This study has been completed.
Information provided by (Responsible Party):
Dr. Sven Poli, University Hospital Heidelberg Identifier:
First received: March 31, 2012
Last updated: April 25, 2012
Last verified: April 2012
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.

Condition Intervention Phase
Ischemic Stroke
Hemorrhagic Stroke
Device: RhinoChill
Drug: Cold crystalloid infusions, 0.9%NaCl or Ringer's solution
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: iCOOL 1 (Induction of COOLing 1): A Randomized Trial Comparing 2 Methods for Rapid Induction of Cooling in Stroke Patients, Cold Infusions vs. RhinoChill

Further study details as provided by University Hospital Heidelberg:

Primary Outcome Measures:
  • Brain temperature [ Time Frame: -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 Outcome Measures:
  • (Neuro-)vital parameters [ Time Frame: -15 to +60 min ]
    Effects on (neuro-)vital parameters (e.g. HR, AP, ICP, CPP) are registered.

  • Cerebral autoregulation [ Time Frame: -15 to +60 min ]
    Cerebral auto-regulation parameters (e.g. PRx) are calculated on the basis of the (neuro-)vital parameters monitored.

  • Safety [ Time Frame: 0-6 months ]
    Various safety parameters, such as bleeding complications, cardiac decompensation, or local irritations in the nasopharynx are assessed.

Enrollment: 20
Study Start Date: September 2010
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cold infusions
Infusion of 2L cold crystalloid solution (4°C) over 30 minutes
Drug: Cold crystalloid infusions, 0.9%NaCl or Ringer's solution
Infusion of 2L cold crystalloid solution (4°C) over 30 minutes
Active Comparator: RhinoChill
Nasopharyngeal cooling with the RhinoChill device (BeneChill, USA)
Device: RhinoChill
Nasopharyngeal cooling with the RhinoChill device
Other Name: BeneChill, USA


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
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Please refer to this study by its identifier: NCT01573117

Neuro Intensive Care Unit 2, Dept. of Neurology, University Hospital Heidelberg
Heidelberg, Germany, 69120
Sponsors and Collaborators
University Hospital Heidelberg
Principal Investigator: Sven Poli, Dr. med. University Hospital Heidelberg
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr. Sven Poli, Consultant Neurologist, Principal Investigator, University Hospital Heidelberg Identifier: NCT01573117     History of Changes
Other Study ID Numbers: iCOOL 1
Study First Received: March 31, 2012
Last Updated: April 25, 2012

Keywords provided by University Hospital Heidelberg:
induction of hypothermia
cold infusion
nasopharyngeal cooling
intracranial hemorrhage
cerebrovascular disease
neuro intensive care

Additional relevant MeSH terms:
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pharmaceutical Solutions processed this record on April 24, 2017