A Randomized Trial Comparing 2 Methods for Rapid Induction of Cooling in Stroke Patients, Cold Infusions vs. RhinoChill (iCOOL 1) (iCOOL 1)
Primary Purpose
Ischemic Stroke, Hemorrhagic Stroke
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
RhinoChill
Cold crystalloid infusions, 0.9%NaCl or Ringer's solution
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Stroke focused on measuring hypothermia, induction of hypothermia, cold infusion, nasopharyngeal cooling, stroke, intracranial hemorrhage, cerebrovascular disease, neuro intensive care
Eligibility 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)
Sites / Locations
- Neuro Intensive Care Unit 2, Dept. of Neurology, University Hospital Heidelberg
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Cold infusions
RhinoChill
Arm Description
Infusion of 2L cold crystalloid solution (4°C) over 30 minutes
Nasopharyngeal cooling with the RhinoChill device (BeneChill, USA)
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
(Neuro-)vital parameters
Effects on (neuro-)vital parameters (e.g. HR, AP, ICP, CPP) are registered.
Cerebral autoregulation
Cerebral auto-regulation parameters (e.g. PRx) are calculated on the basis of the (neuro-)vital parameters monitored.
Safety
Various safety parameters, such as bleeding complications, cardiac decompensation, or local irritations in the nasopharynx are assessed.
Full Information
NCT ID
NCT01573117
First Posted
March 31, 2012
Last Updated
April 25, 2012
Sponsor
University Hospital Heidelberg
1. Study Identification
Unique Protocol Identification Number
NCT01573117
Brief Title
A Randomized Trial Comparing 2 Methods for Rapid Induction of Cooling in Stroke Patients, Cold Infusions vs. RhinoChill (iCOOL 1)
Acronym
iCOOL 1
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 Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Heidelberg
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke, Hemorrhagic Stroke
Keywords
hypothermia, induction of hypothermia, cold infusion, nasopharyngeal cooling, stroke, intracranial hemorrhage, cerebrovascular disease, neuro intensive care
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cold infusions
Arm Type
Active Comparator
Arm Description
Infusion of 2L cold crystalloid solution (4°C) over 30 minutes
Arm Title
RhinoChill
Arm Type
Active Comparator
Arm Description
Nasopharyngeal cooling with the RhinoChill device (BeneChill, USA)
Intervention Type
Device
Intervention Name(s)
RhinoChill
Other Intervention Name(s)
BeneChill, USA
Intervention Description
Nasopharyngeal cooling with the RhinoChill device
Intervention Type
Drug
Intervention Name(s)
Cold crystalloid infusions, 0.9%NaCl or Ringer's solution
Intervention Description
Infusion of 2L cold crystalloid solution (4°C) over 30 minutes
Primary Outcome Measure Information:
Title
Brain temperature
Description
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
Secondary Outcome Measure Information:
Title
(Neuro-)vital parameters
Description
Effects on (neuro-)vital parameters (e.g. HR, AP, ICP, CPP) are registered.
Time Frame
-15 to +60 min
Title
Cerebral autoregulation
Description
Cerebral auto-regulation parameters (e.g. PRx) are calculated on the basis of the (neuro-)vital parameters monitored.
Time Frame
-15 to +60 min
Title
Safety
Description
Various safety parameters, such as bleeding complications, cardiac decompensation, or local irritations in the nasopharynx are assessed.
Time Frame
0-6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sven Poli, Dr. med.
Organizational Affiliation
University Hospital Heidelberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neuro Intensive Care Unit 2, Dept. of Neurology, University Hospital Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
25346332
Citation
Poli S, Purrucker J, Priglinger M, Ebner M, Sykora M, Diedler J, Bulut C, Popp E, Rupp A, Hametner C. Rapid Induction of COOLing in Stroke Patients (iCOOL1): a randomised pilot study comparing cold infusions with nasopharyngeal cooling. Crit Care. 2014 Oct 27;18(5):582. doi: 10.1186/s13054-014-0582-1.
Results Reference
derived
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A Randomized Trial Comparing 2 Methods for Rapid Induction of Cooling in Stroke Patients, Cold Infusions vs. RhinoChill (iCOOL 1)
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