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

Recruiting

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. EMCOOLS Flex.Pads (Emergency Medical Cooling Systems AG, Wien, Austria) is a new non-invasive surface cooling system. A comparison of these two induction methods has never been done before. Neither was the effect of EMCOOLS Flex.Pads on brain-temperature measured. For the first time iCOOL 2 compares feasibility, safety and efficacy of the two methods.

Conditions

Interventions

  • 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
  • EMCOOLS Flex.Pads Device
    Other Names: Emergency Medical Cooling Systems AG, Wien, Austria
    Intervention Desc: Passive whole-body surface cooling with 10 EMCOOLS Flex.Pads
    ARM 1: Kind: Experimental
    Label: EMCOOLS Flex.Pads
    Description: Passive surface cooling with 10 EMCOOLS Flex.Pads (Emergency Medical Cooling Systems AG, Wien, Austria)

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Brain temperature 1 h No
Secondary (Neuro-)vital parameters -15 to +180 min Yes
Secondary Cerebral autoregulation 15 to +180 min No
Secondary Safety 0 - 7 days Yes

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