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

Stroke Clinical Trial

— CryoCollar  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02703675
• Other study ID #: 2015H0207
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: June 12, 2018

Study information

• Verified date: June 2018
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: June 12, 2018
• Est. primary completion date: June 12, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Michel Torbey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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