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

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

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.

Study Overview

• Status: Completed
• Conditions: Ischemic Stroke; Hemorrhagic Stroke
• Intervention / Treatment: Drug: Cold crystalloid infusions, 0.9%NaCl or Ringer's solution; Device: RhinoChill

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Heidelberg, Germany, 69120
    • Neuro Intensive Care Unit 2, Dept. of Neurology, University Hospital Heidelberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: BeneChill, USA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	-15 to +60min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
(Neuro-)vital parameters	Effects on (neuro-)vital parameters (e.g. HR, AP, ICP, CPP) are registered.	-15 to +60 min
Cerebral autoregulation	Cerebral auto-regulation parameters (e.g. PRx) are calculated on the basis of the (neuro-)vital parameters monitored.	-15 to +60 min
Safety	Various safety parameters, such as bleeding complications, cardiac decompensation, or local irritations in the nasopharynx are assessed.	0-6 months

Collaborators and Investigators

• Sponsor: University Hospital Heidelberg
• Investigators: Principal Investigator: Sven Poli, Dr. med., University Hospital Heidelberg

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: March 31, 2012
• First Submitted That Met QC Criteria: April 4, 2012
• First Posted (Estimate): April 6, 2012

Study Record Updates

• Last Update Posted (Estimate): April 26, 2012
• Last Update Submitted That Met QC Criteria: April 25, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: stroke; hypothermia; intracranial hemorrhage; cerebrovascular disease; induction of hypothermia; cold infusion; nasopharyngeal cooling; neuro intensive care
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Hemorrhagic Stroke
• Other Study ID Numbers: iCOOL 1