Effectiveness, Safety and Ease of Application of Excel Cryo Cooling Collar to Rapidly Reduce Core Brain Temperature

2016-03-10 03:23:23 | BioPortfolio


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 patient 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 subjects:

i. Healthy adult volunteers, ii. Adult patients with normal body temperature in intensive care unit iii. Adult patients with fever in intensive care unit


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 patients and 10 adult sick febrile patients from Neurocritical Care ICU in The Ohio State University Wexner Medical Center. Before placing the collar around patient's neck, the investigators will record the patient's ear temperature and heart rate as a baseline. An Excel Cryo Collar will be placed around the patient's neck. After activating the cooling element, the investigators will place it within the neck collar.

The patient's ear temperature will be recorded every 5 minutes. The investigators will replace the cooling element every 20 minutes and continue to record the patient'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 patient will be checked and recorded every 20 minutes when cooling element is replaced. The patient's bedside shivering assessment scale (BSAS) will also be recorded during the study.

Five adult sick febrile patients will receive 2 rounds of cooling procedure each 2 hours long.

We will analyze data gathered from the study in 2 different ways:

First, we will run descriptive statistics in three groups of subject 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, we will compare the difference in achieving temperature drop among three groups by comparing mean values of temperature drop in three groups.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment




Excel Cryo Cooling Collar


The Ohio State University Wexner Medical Center
United States




Ohio State University

Results (where available)

View Results


Published on BioPortfolio: 2016-03-10T03:23:23-0500

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ANESTHESIA achieved by lowering either BODY TEMPERATURE (core cooling) or SKIN TEMPERATURE (external cooling).

Restoration of functions to the maximum degree possible in a person or persons suffering from a stroke.

A group of conditions due to overexposure to or overexertion in excess environmental temperature. It includes heat cramps, which are non-emergent and treated by salt replacement; HEAT EXHAUSTION, which is more serious, treated with fluid and salt replacement; and HEAT STROKE, a condition most commonly affecting extremes of age, especially the elderly, accompanied by convulsions, delusions, or coma and treated with cooling the body and replacement of fluids and salts. (From Segen, Dictionary of Modern Medicine, 1992)

Stroke caused by lacunar infarction or other small vessel diseases of the brain. It features hemiparesis (see PARESIS), hemisensory, or hemisensory motor loss.

A group of pathological conditions characterized by sudden, non-convulsive loss of neurological function due to BRAIN ISCHEMIA or INTRACRANIAL HEMORRHAGES. Stroke is classified by the type of tissue NECROSIS, such as the anatomic location, vasculature involved, etiology, age of the affected individual, and hemorrhagic vs. non-hemorrhagic nature. (From Adams et al., Principles of Neurology, 6th ed, pp777-810)

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