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| Name | Class |
|---|---|
| Gaymar Industries, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Application of the Gaymar Rapr-Round device per approved use |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gaymar Rapr-Round (external cooling blanket) | Device | Application of the device per its approved labeling |
|
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew M Naidech, MD MSPH | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Group | Application of the Gaymar Rapr-Round device per FDA-approved use (temperature reduction in patients with fever in a monitored setting) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Group | Application of the Gaymar Rapr-Round device per FDA-approved use (temperature reduction in patients with fever in a monitored setting) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | degrees F | baseline, one, two and six hours after application. |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Group | Application of the Gaymar Rapr-Round device per FDA-approved use (temperature reduction in patients with fever in a monitored setting) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Shivering | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Andrew Naidech | Northwestern University | 312-503-3335 | a-naidech@northwestern.edu |
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| ID | Term |
|---|---|
| D005334 | Fever |
| D020300 | Intracranial Hemorrhages |
| D013345 | Subarachnoid Hemorrhage |
| D002543 | Cerebral Hemorrhage |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
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Severe shivering as measured by the bedside shivering assessment scale: 0 None: no shivering noted on palpation of the masseter, neck, or chest wall
|
| 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 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | hours | Six hours |
|
|
|
| Secondary | 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
| All participants were analyzed for the outcome of BSAS=3 | Posted | Number | participants | six hours |
|
|
|
| Secondary | Number of Participants With Hypotension | New systolic blood pressure < 100 mm Hg, or new vasopressor use during study period | Posted | Number | participants | six hours |
|
|
|
| Secondary | Number of Participants With Arrhythmia | New ventricular tachycardia, ventricular fibrillation, atrial fibrillation or other unstable cardiac rhythm | Posted | Number | participants | Six hours |
|
|
|
| 4 |
| 20 |
| 0 |
| 20 |
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| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |