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

Completed · Not applicable

Conditions studied: Stroke

In brief

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

Key facts

Study ID

NCT02703675

Run by

Michel Torbey

People needed

8

Starts

2016-02-01

Expected to finish

2018-06-12

Last updated by the study team

2018-07-02

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• The Ohio State University Wexner Medical Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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