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

Completed

Phase 2 Results N/A

Trial Description

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

Interventions

  • Rhinochill Device
    Other Names: BeneChill, USA
    Intervention Desc: Nasopharyngeal cooling with the RhinoChill device
    ARM 1: Kind: Experimental
    Label: RhinoChill
    Description: Nasopharyngeal cooling with the RhinoChill device (BeneChill, USA)
  • Device for nasopharyngeal cooling, RhinoChill(R) Device
    Other Names: BeneChill, USA
    Intervention Desc: Nasopharyngeal cooling with the RhinoChill device
    ARM 1: Kind: Experimental
    Label: RhinoChill
    Description: Nasopharyngeal cooling with the RhinoChill device (BeneChill, USA)
  • Cold cristalloid infusions, 0.9%NaCl or Ringer's solution Drug
    Intervention Desc: Infusion of 2L cold cristalloid solution (4°C) over 30 minutes.
    ARM 1: Kind: Experimental
    Label: Cold infusions
    Description: Infusion of 2L cold cristalloid solution (4°C) over 30 minutes.
  • Cold crystalloid infusions, 0.9%NaCl or Ringer's solution Drug
    Intervention Desc: Infusion of 2L cold crystalloid solution (4°C) over 30 minutes
    ARM 1: Kind: Experimental
    Label: Cold infusions
    Description: Infusion of 2L cold crystalloid solution (4°C) over 30 minutes

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Decrease in brain temperature 1 h No
Secondary Effects on (neuro-)vital parameters -15 to +60 min Yes
Secondary Effects on cerebral autoregulation -15 to +60 min No
Secondary Safety monitoring 0-6 months Yes
Primary Brain temperature 1 h No
Secondary (Neuro-)vital parameters -15 to +60 min Yes
Secondary Cerebral autoregulation -15 to +60 min No
Secondary Safety 0-6 months Yes

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