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

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

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Male or female 18-60 years of age
Computed Tomography Angiography (CTA) image results show no narrow in carotid artery (not applied to healthy volunteers)
Be able to accept cooling procedure at least 2 hours
Provide informed consent.

Exclusion criteria

Patients with increased intracerebral pressure (ICP), intracerebral hemorrhage (ICH) and carotid artery stenosis
Receiving external ventricular drainage
Taking anti-febrile medications within 4 hours
Females who are pregnant or breastfeeding
Subjects who have arrhythmia, other serious cardiac disease, or low blood pressure
Subject has a higher body mass index (BMI>35)
Receiving jugular IV catheter
Skin wound around the neck

Treatment and study plan

Excel Cryo Cooling Collar

Device

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.

Primary outcomes

Therapeutic hypothermia measured by tympanic temperature

Time frame: 6 hours

The tympanic temperature in Celsius will be detected in adult healthy volunteers, adult normothermic patients and adult sick febrile patients after receiving one or two rounds of cooling process.

Sponsors and collaborators

Lead sponsor

Michel Torbey

Other

Registry information

Acronym: CryoCollar

Important dates

Study start: 2016
Primary completion: 2018
Study completion: 2018
First posted: Mar 9, 2016
Registry last updated: Jul 2, 2018

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.

Published trials that share one or more normalized conditions with this study.

Completed