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Completed

NCT Number: NCT01573117

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

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.

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Key information

Conditions

Ischemic Stroke Body Temperature Changes Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemorrhage Hemorrhagic Stroke Hypothermia Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Heidelberg, 69120, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

RhinoChill

Device

Nasopharyngeal cooling with the RhinoChill device

Other names: BeneChill, USA

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

Drug

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

Primary outcomes

  1. Brain temperature

    Time frame: -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 outcomes

  1. (Neuro-)vital parameters

    Time frame: -15 to +60 min

    Effects on (neuro-)vital parameters (e.g. HR, AP, ICP, CPP) are registered.

  2. Cerebral autoregulation

    Time frame: -15 to +60 min

    Cerebral auto-regulation parameters (e.g. PRx) are calculated on the basis of the (neuro-)vital parameters monitored.

  3. Safety

    Time frame: 0-6 months

    Various safety parameters, such as bleeding complications, cardiac decompensation, or local irritations in the nasopharynx are assessed.

Sponsors and collaborators

Lead sponsor

University Hospital Heidelberg

Other

Registry information

Official study 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

Acronym: iCOOL 1

Important dates

Study start
2010
Primary completion
2011
First posted
Apr 6, 2012
Registry last updated
Apr 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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