Clinical trial NCT01573117: A Randomized Trial Comparing 2 Methods for Rapid Induction of Cooling in Stroke Patients, Cold Infusions vs. RhinoChill (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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ischemic Stroke
Hemorrhagic Stroke
Keywords: hypothermia
induction of hypothermia
cold infusion
nasopharyngeal cooling
stroke
intracranial hemorrhage
cerebrovascular disease
neuro intensive care
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
First posted: 2012-04-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Brain temperature
timeFrame: -15 to +60min
Secondary outcomes:
measure: (Neuro-)vital parameters
timeFrame: -15 to +60 min
measure: Cerebral autoregulation
timeFrame: -15 to +60 min
measure: Safety
timeFrame: 0-6 months
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Neuro Intensive Care Unit 2, Dept. of Neurology, University Hospital Heidelberg
Study officials:
affiliation: University Hospital Heidelberg
name: Sven Poli, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
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.