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

Phase 2

Completed

• Conditions: Ischemic Stroke; Hemorrhagic Stroke
• Interventions: Drug: Cold crystalloid infusions, 0.9%NaCl or Ringer's solution; Device: RhinoChill

• Registration Number: NCT01573117
• Lead Sponsor: University Hospital Heidelberg

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Primary Completion: 2011-11
• Study First Submitted: 2012-03-31
• Status Verified: 2012-04
• Study First Submitted QC: 2012-04-04
• Study First Posted: 2012-04-06
• Last Update Submitted: 2012-04-25
• Last Update Posted: 2012-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cold infusions	Cold crystalloid infusions, 0.9%NaCl or Ringer's solution	Infusion of 2L cold crystalloid solution (4°C) over 30 minutes
RhinoChill	RhinoChill	Nasopharyngeal cooling with the RhinoChill device (BeneChill, USA)

Primary Outcome Measures

Name	Time	Method
Brain temperature	-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

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

Trial Locations

Locations (1)

Neuro Intensive Care Unit 2, Dept. of Neurology, University Hospital Heidelberg; 🇩🇪 Heidelberg, Germany