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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)

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ClinicalTrials.gov Identifier: NCT01573117
Recruitment Status : Completed
First Posted : April 6, 2012
Last Update Posted : April 26, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Ischemic Stroke Hemorrhagic Stroke Device: RhinoChill Drug: Cold crystalloid infusions, 0.9%NaCl or Ringer's solution Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : September 2010
Primary Completion Date : November 2011
Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. (Neuro-)vital parameters [ Time Frame: -15 to +60 min ]
    Effects on (neuro-)vital parameters (e.g. HR, AP, ICP, CPP) are registered.

  2. 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.

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


Eligibility Criteria

Information from the National Library of Medicine

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

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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01573117


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Sven Poli, Consultant Neurologist, Principal Investigator, University Hospital Heidelberg
ClinicalTrials.gov Identifier: NCT01573117     History of Changes
Other Study ID Numbers: iCOOL 1
First Posted: April 6, 2012    Key Record Dates
Last Update Posted: April 26, 2012
Last Verified: April 2012

Keywords provided by Dr. Sven Poli, University Hospital Heidelberg:
hypothermia
induction of hypothermia
cold infusion
nasopharyngeal cooling
stroke
intracranial hemorrhage
cerebrovascular disease
neuro intensive care

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pharmaceutical Solutions