The objective of this study is to evaluate the efficacy of the COOLSTAT® Transnasal Thermal Regulating Device in reducing temperature in a population of febrile subjects who meet the inclusion/exclusion criteria.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Placement of transnasal thermal regulating device to reduce temperature in febrile patients for a period of 24 hours
University of Maryland Medical Center
Baltimore, Maryland, United States
Time to achieve normothermia (≤37.5°C)
To evaluate the efficacy of the COOLSTAT® in reducing temperature in a population of febrile subjects who meet the inclusion/exclusion criteria.
Time frame: 24 hours
Temperature burden above 37.5°C (°C*hours) during the 24-hour cooling period
To evaluate the efficacy of the COOLSTAT® in maintaining normothermia over a 24-hour cooling period
Time frame: 24 hours
Incidence of shivering during cooling period
To assess the frequency of shivering incidents caused by the CoolStat device.
Time frame: 24 hours
Number of shivering interventions per patient
To assess the frequency shivering interventions caused by the CoolStat device.
Time frame: 24 hours
Incidence of adverse events.
To evaluate the safety of the CoolStat device.
Time frame: 24 hours
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