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Clinical Trial Summary

The purpose of this study is to determine if cooling the neck of patients with ICH decreases brain temperature. In addition, the investigators will determine if the device improves the delivery of oxygen to the brain. A third goal is to determine if cooling the neck lowers intracranial pressure (which is often times high in patients after ICH).


Clinical Trial Description

This is a non-randomized device efficacy trial. Patients with >20cc Supratentorial ICH and an invasive brain temperature monitor (either Licox or Temperature sensing intracranial pressure device) will be enrolled after consent. The Excel Cryo Cooling System collar will be placed around neck in up to 20 patients for two hours. The goal is to determine the effectiveness of this device in cooling the brain. The collar is a standard neck collar used for patients after neck surgery with a modification that allows for the placement of a cooling pack in the collar that delivers the cold. During the study and for two hours after, the investigators will collect data concerning the brain temperature, body temperature, brain oxygen level and pressure both in the head and in the blood (blood pressure). The investigators will also collect demographic information about you (i.e. age, gender, medical risk factors) and information regarding your current disease process. ;


Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label


Related Conditions & MeSH terms


NCT number NCT01933230
Study type Interventional
Source The Cleveland Clinic
Contact
Status Terminated
Phase Phase 1
Start date June 2013
Completion date September 2014

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