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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Sven Poli, University Hospital Heidelberg
ClinicalTrials.gov Identifier:
NCT01573117
First received: March 31, 2012
Last updated: April 25, 2012
Last verified: April 2012
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by University Hospital Heidelberg:

Primary Outcome Measures:
  • Brain temperature [ Time Frame: -15 to +60min ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Effects on (neuro-)vital parameters (e.g. HR, AP, ICP, CPP) are registered.

  • Cerebral autoregulation [ Time Frame: -15 to +60 min ] [ Designated as safety issue: No ]
    Cerebral auto-regulation parameters (e.g. PRx) are calculated on the basis of the (neuro-)vital parameters monitored.

  • Safety [ Time Frame: 0-6 months ] [ Designated as safety issue: Yes ]
    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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
No publications provided

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
Study First Received: March 31, 2012
Last Updated: April 25, 2012
Health Authority: Germany: Ethics Commission

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

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014