Effectiveness, Safety and Ease of Application of Excel Cryo Cooling Collar to Rapidly Reduce Core Brain Temperature
CryoCollar
1 other identifier
interventional
8
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable stroke
Started Feb 2016
Typical duration for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 15, 2016
CompletedStudy Start
First participant enrolled
February 1, 2016
CompletedFirst Posted
Study publicly available on registry
March 9, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 12, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 12, 2018
CompletedJuly 2, 2018
June 1, 2018
2.4 years
January 15, 2016
June 28, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Therapeutic hypothermia measured by tympanic temperature
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.
6 hours
Study Arms (3)
adult healthy volunteer
EXPERIMENTALAdult 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.
adult normothermic patient
EXPERIMENTALAdult 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.
adult sick febrile patient
EXPERIMENTALAdult 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
Interventions
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
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Michel Torbeylead
Study Sites (1)
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michel Torbey, MD
Ohio State University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 15, 2016
First Posted
March 9, 2016
Study Start
February 1, 2016
Primary Completion
June 12, 2018
Study Completion
June 12, 2018
Last Updated
July 2, 2018
Record last verified: 2018-06
Data Sharing
- IPD Sharing
- Will not share