Topics

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

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

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 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

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 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

Conditions

Stroke

Intervention

Excel Cryo Cooling Collar

Location

The Ohio State University Wexner Medical Center
Columbus
Ohio
United States
43210

Status

Recruiting

Source

Ohio State University

Results (where available)

View Results

Links

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

Clinical Trials [2356 Associated Clinical Trials listed on BioPortfolio]

Cryo Pack Cooling After Exercise-induced Hyperthermia

This research study aims to examine whether Cryo Cooling packs reduce thermal and cardiovascular strain after exercise-induced hyperthermia compared to a commercially available ice pack. S...

Tarp Assisted Cooling of Hyperthermic Individuals

This is a randomized controlled trial exploring the difference in cooling rates between two treatments: 1) tarp-assisted cooling and 2) the standard of care for heat stroke treatment in th...

Body Cooling in Hyperthermic Males and Females

Exertional heat stroke (EHS) is an emergency medical condition that is prevalent in military soldiers, athletes, and laborers. It is diagnosed when the rectal temperature is above 40°C wi...

Efficacy of an Investigational Thermal Rehab Machine on Body Cooling in Hyperthermic Individuals

Exertional heat stroke (EHS) is an emergency medical condition that is prevalent in military soldiers, athletes, and laborers. It is diagnosed when the rectal temperature is above 40°C wi...

"The Length of Cervical Collar Treatment for Traumatic Sub-axial Fractures"

Most fractures of the cervical spine are considered stable and treated with a rigid cervical collar. However no studies have to date been published addressing the length of treatment. Ther...

PubMed Articles [2540 Associated PubMed Articles listed on BioPortfolio]

Breastfeeding Knowledge, Attitude, and Practice among White-Collar and Blue-Collar Workers in Indonesia.

Working status is identified as a major risk factor of poor breastfeeding practices among workers. This study aimed to evaluate the knowledge, attitude, and factors associated with breastfeeding pract...

Effect of a neck compression collar on cardiorespiratory and cerebrovascular function in Postural Orthostatic Tachycardia Syndrome (POTS).

Postural orthostatic tachycardia syndrome (POTS) is accompanied by reduced brain blood flow, autonomic dysfunction, and orthostatic intolerance. We hypothesized that wearing a neck compression collar ...

BB0326 is responsible for the formation of periplasmic flagellar collar and the assembly of the stator complex in Borrelia burgdorferi.

Borrelia burgdorferi is a highly motile spirochete due to its periplasmic flagella. Unlike flagella of other bacteria, spirochetes' periplasmic flagella possess a complex structure called the collar, ...

Mechanism of freezing resistance in eco-dormant birch buds under winter subzero temperatures.

Maximum freezing resistance is a component of winter survival and is associated with the eco-dormant state. Differential thermal analysis (DTA) has shown that changes of the freezing response of the d...

Electron cryo-microscopy for elucidating the dynamic nature of live-protein complexes.

Recent innovations in the field of electron cryo-microscopy (cryo-EM) have achieved structure determination of target macromolecules at "near-atomic resolution". In addition, cryo-EM has the potential...

Medical and Biotech [MESH] Definitions

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)

More From BioPortfolio on "Effectiveness, Safety and Ease of Application of Excel Cryo Cooling Collar to Rapidly Reduce Core Brain Temperature"

Quick Search

Relevant Topics

Cardiovascular disease (CVD)
Acute Coronary Syndromes (ACS) Blood Cardiovascular Dialysis Hypertension Stent Stroke Vascular Cardiovascular disease (CVD) includes all the diseases of the heart and circulation including coronary heart disease (angina...

Women's Health
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...


Searches Linking to this Trial