Temperature Control in Central Fever in the Neuro-ICU

Study Overview
=================
Brief Summary
-----------------
There are few treatments for central fever (fever that is due to the central nervous system, as opposed to an infectious source). We hypothesize that an externally applied cooling blanket will reduce temperature in neurologically ill patients with central fever.

Official Title
-----------------
Temperature Control in Central Fever in the Neuro-ICU

Conditions
-----------------
Fever, Brain Hemorrhage

Intervention / Treatment
-----------------
* Device: Gaymar Rapr-Round (external cooling blanket)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Two or more days with core temperature ≥ 100.4F Approval of the patient's primary attending physician Need for core temperature measurement independent of the study. Admission to the Neuro-ICU [intensive care unit] for an underlying condition Exclusion Criteria: Evidence for an infectious cause of fever, such as pneumonia, bacteremia, CNS [central nervous system] infection or urinary tract infection. Expected death from any cause Known sensitivity to the device History of pre-admission hypothalamic dysfunction or known temperature dysregulation Use of 2 or more vasopressor medications, since this may make a local skin reaction to the device more likely Hemodynamic instability

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Application of the Gaymar Rapr-Round device per approved use | Device: Gaymar Rapr-Round (external cooling blanket)<br>* Application of the device per its approved labeling<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Core Temperature as Measured With an Approved Device (Urinary Catheter) in Place for Usual Clinical Care | Core temperature (in degrees Fahrenheit, F) throughout the study period. The cooling blanket was in place throughout the study period unless severe shivering led to termination per protocol. | baseline, one, two and six hours after application. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time From Start of Cooling Device to Core Temperature < 100.4F | For all patients, the time until the core temperature (measured with a urinary catheter in place for usual clinical care) was <100.4F | Six hours | 
| Number of Participants With Severe Shivering | Severe shivering as measured by the bedside shivering assessment scale: 0 None: no shivering noted on palpation of the masseter, neck, or chest wall Mild: shivering localized to the neck and/or thorax only Moderate: shivering involves gross movement of the upper extremities (in addition to neck and thorax) Severe: shivering involves gross movements of the trunk and upper and lower extremities | six hours | 
| Number of Participants With Hypotension | New systolic blood pressure < 100 mm Hg, or new vasopressor use during study period | six hours | 
| Number of Participants With Arrhythmia | New ventricular tachycardia, ventricular fibrillation, atrial fibrillation or other unstable cardiac rhythm | Six hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
subarachnoid hemorrhage, intracerebral hemorrhage, fever