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

NCT ID: NCT01573117

Last Updated: 2012-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30

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.

Conditions

Ischemic Stroke; Hemorrhagic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cold infusions

Infusion of 2L cold crystalloid solution (4°C) over 30 minutes

Group Type: ACTIVE_COMPARATOR

Cold crystalloid infusions, 0.9%NaCl or Ringer's solution

Intervention Type: DRUG

Infusion of 2L cold crystalloid solution (4°C) over 30 minutes

RhinoChill

Nasopharyngeal cooling with the RhinoChill device (BeneChill, USA)

Group Type: ACTIVE_COMPARATOR

RhinoChill

Intervention Type: DEVICE

Nasopharyngeal cooling with the RhinoChill device

Interventions

RhinoChill

Nasopharyngeal cooling with the RhinoChill device

Intervention Type: DEVICE

Cold crystalloid infusions, 0.9%NaCl or Ringer's solution

Infusion of 2L cold crystalloid solution (4°C) over 30 minutes

Intervention Type: DRUG

Other Intervention Names

BeneChill, USA

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Heidelberg

OTHER

Sponsor Role: lead

Responsible Party

Dr. Sven Poli

Consultant Neurologist, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sven Poli, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Heidelberg

Locations

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

Heidelberg, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 25346332 (View on PubMed)

Other Identifiers

iCOOL 1

Identifier Type: -

Identifier Source: org_study_id