Effectiveness, Safety and Ease of Application of Excel Cryo Cooling Collar to Rapidly Reduce Core Brain Temperature
Condition: Stroke
Study type: Interventional

Summary: 
      Research has shown that lowering brain temperature may have good results in heart attack
      patients. Lowering brain temperature may be a promising treatment for stroke patients. The
      Excel Cryo Cooling device drops brain temperature by cooling the blood in arteries in the
      neck. The device is a neck collar with a cooling pack which when shaken can reach low
      temperature within seconds. The collar is placed around the patient's neck and the cooling
      pack is applied to the front of the neck and held in place. This device provides stable
      cooling irrespective of participant size or weight. The objective of this study is to test
      the value of using Excel Cryo Cooling device in dropping brain temperature in 3 different
      groups of adult participants:

      i. Healthy adult volunteers, ii. Adult participants with normal body temperature in intensive
      care unit iii. Adult participants with fever in intensive care unit
    

Detailed description: 
      To investigate effectiveness, safety and ease of application of Cryo Collar to rapidly reduce
      core brain temperature, the study will recruit 8 healthy volunteers, 10 adult normothermic
      participants and 10 adult sick febrile participants from Neurocritical Care ICU in The Ohio
      State University Wexner Medical Center. Before placing the collar around participant's neck,
      the investigators will record the participant's ear temperature and heart rate as a baseline.
      An Excel Cryo Collar will be placed around the participant's neck. After activating the
      cooling element, the investigators will place it within the neck collar.

      The participant's ear temperature will be recorded every 5 minutes. The investigators will
      replace the cooling element every 20 minutes and continue to record the participant's ear
      temperature every 5 minutes. A total of 6 cooling elements will be used over 2 hours. The
      heart rate and blood pressure of the participant will be checked and recorded every 20
      minutes when cooling element is replaced. The participant's bedside shivering assessment
      scale (BSAS) will also be recorded during the study.

      Five adult sick febrile participants will receive 2 rounds of cooling procedure each 2 hours
      long.

      The investigators will analyze data gathered from the study in 2 different ways:

      First, the investigators will run descriptive statistics in three groups of participant to
      find out the following variable: Average temperature drop, average time to mild therapeutic
      hypothermia and change in temperature at the end of study.

      Second, the investigators will compare the difference in achieving temperature drop among
      three groups by comparing mean values of temperature drop in three groups.
    

Intervention name(s): Excel Cryo Cooling Collar
Intervention type(s): Device
Intervention description(s): Therapeutic hypothermia in the study will be initiated by The Excel Cryo Cooling system consisting of a unique cervical immobilization collar and a cooling element. Once activated, the cooling element achieves a temperature of -3.0 °C to -5.0 °C within seconds. The collar is fitted around the subject's neck and the cooling element is applied the the front of the neck over the carotid arteries and secured in place by the collar. The Excel System provides consistent cooling regardless of patient size or weight, by cooling of the blood traveling through the carotid triangles.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment