Effectiveness, Safety and Ease of Application of Excel Cryo Cooling Collar to Rapidly Reduce Core Brain Temperature
NCT ID: NCT02703675
Last Updated: 2018-07-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
8 participants
INTERVENTIONAL
2016-02-29
2018-06-12
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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adult healthy volunteer
Adult healthy volunteers will be recruited from staff in Dept. Neurology, medical students. They will receive a cooling procedure by using the Excel Cryo Cooling Collar around their neck and fitted with activated cooling element for 2 hours.
Excel Cryo Cooling Collar
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.
adult normothermic patient
Adult normothermic patients will be recruited from Neurocritical Care ICU in The Ohio State University Wexner Medical Center.
They will receive a cooling procedure by using the Excel Cryo Cooling Collar around their neck and fitted with activated cooling element for 2 hours.
Excel Cryo Cooling Collar
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.
adult sick febrile patient
Adult sick febrile patients will be enrolled from Neurocritical Care ICU in The Ohio State University Wexner Medical Center.
Five of the patients will receive a cooling procedure by using the Excel Cryo Cooling Collar around their neck and fitted with activated cooling element for 2 hours.
Other five patients will received 2 rounds of cooling process each 2 hours long
Excel Cryo Cooling Collar
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.
Interventions
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Excel Cryo Cooling Collar
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
ALL
Yes
Sponsors
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Michel Torbey
OTHER
Responsible Party
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Michel Torbey
Professor
Principal Investigators
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Michel Torbey, MD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University
Locations
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The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Countries
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Other Identifiers
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2015H0207
Identifier Type: -
Identifier Source: org_study_id
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