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

Sponsor

Michel Torbey (Other)

Overall Status

Completed

CT.gov ID

NCT02703675

Collaborator

(none)

Enrollment

Location

Arms

28.3

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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:

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

Condition or Disease	Intervention/Treatment	Phase
Stroke	Device: Excel Cryo Cooling Collar	N/A

Detailed 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 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

8 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2016

Actual Primary Completion Date :

Jun 12, 2018

Actual Study Completion Date :

Jun 12, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: 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.
Experimental: 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.	Device: 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.
Experimental: 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	Device: 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.

Arm

Intervention/Treatment

Experimental: 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.

Device: 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.

Experimental: 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.

Device: Excel Cryo Cooling Collar

Experimental: 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

Device: Excel Cryo Cooling Collar

Outcome Measures

Primary Outcome Measures

Therapeutic hypothermia measured by tympanic temperature [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Ohio State University Wexner Medical Center	Columbus	Ohio	United States	43210

Sponsors and Collaborators

Michel Torbey

Investigators

Principal Investigator: Michel Torbey, MD, The Ohio State University Wexner Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Michel Torbey, Professor, Ohio State University

ClinicalTrials.gov Identifier:

NCT02703675

Other Study ID Numbers:

2015H0207

First Posted:

Mar 9, 2016

Last Update Posted:

Jul 2, 2018

Last Verified:

Jun 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Study Results

No Results Posted as of Jul 2, 2018