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

Ischemic Stroke Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01573117
• Other study ID #: iCOOL 1
• Status: Completed
• Phase: Phase 2
• First received: March 31, 2012
• Last updated: April 25, 2012
• Start date: September 2010

Study information

• Verified date: April 2012
• Source: University Hospital Heidelberg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhagic Stroke
• Ischemic Stroke
• Stroke

Intervention

Device:
• RhinoChill
Nasopharyngeal cooling with the RhinoChill device

Drug:
• Cold crystalloid infusions, 0.9%NaCl or Ringer's solution
Infusion of 2L cold crystalloid solution (4°C) over 30 minutes

Locations

Country	Name	City	State
Germany	Neuro Intensive Care Unit 2, Dept. of Neurology, University Hospital Heidelberg	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Heidelberg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	(Neuro-)vital parameters	Effects on (neuro-)vital parameters (e.g. HR, AP, ICP, CPP) are registered.	-15 to +60 min	Yes
Secondary	Cerebral autoregulation	Cerebral auto-regulation parameters (e.g. PRx) are calculated on the basis of the (neuro-)vital parameters monitored.	-15 to +60 min	No
Secondary	Safety	Various safety parameters, such as bleeding complications, cardiac decompensation, or local irritations in the nasopharynx are assessed.	0-6 months	Yes

External Links

•   Heidelberg HYPOthermia 24/7 - Research group, information and contacts