An interventional study of Transnasal Thermal Regulating Device in Stroke, Ischemic, Stroke Hemorrhagic and Fever, sponsored by CoolTech LLC. Completed at 3 sites in United States. Open to participants aged 18 Years to 95 Years. Per ClinicalTrials.gov, last updated 2023-06-18.
Sponsored by CoolTech LLC · Not applicable, Interventional, and Treatment
The objective of this study is to evaluate safety and performance of the COOLSTAT® Transnasal Thermal Regulating Device in reducing temperature in a population of febrile subjects who meet the inclusion/exclusion criteria.
2,653 studies on the registry are indexed under Ischemic Stroke; 936 are open to participants now.
This study's enrollment of 30 is below the median of 120 across 1,799 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →CoolTech LLC is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Consented subjects will undergo cooling via transnasal thermal regulating device for a period of 8 to 24 hours
Device: Transnasal Thermal Regulating Device
Placement of transnasal thermal regulating device to reduce temperature in febrile patients for a period of 8 to 24 hours
Cooling Performance
Ability of transnasal thermal regulating device to reduce core body temperature within 4 hours of initiation
Time frame: 4 hours
| Milestone | Transnasal Thermal Regulating Device |
|---|---|
| Started | 30 |
| Completed | 30 |
| Not completed | 0 |
Ability of transnasal thermal regulating device to reduce core body temperature within 4 hours of initiation
| Participants | Transnasal Thermal Regulating Device |
|---|---|
| Cooling Performance | 19 |
Collected over Adverse events were collected during a 48 hour period, starting when the subject was placed on CoolStat, during the 24 hour cooling period, and for the 24 hour post-cooling observation period.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Transnasal Thermal Regulating Device | 0/30 (0%) | 0/30 (0%) | 15/30 (50%) |
| Event | Transnasal Thermal Regulating Device |
|---|---|
| ShiveringNervous system disorders | 9/30 |
| Insufficient coolingNervous system disorders | 5/30 |
| Adverse effects on systemic blood pressureCardiac disorders | 3/30 |
30
| Age, Categorical(Participants) | Transnasal Thermal Regulating Device |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 17 |
| >=65 years | 13 |
| Age, Continuous(years) | Transnasal Thermal Regulating Device |
|---|---|
| Mean | 61.93 ± 15.87 |
| Sex: Female, Male(Participants) | Transnasal Thermal Regulating Device |
|---|---|
| Female | 11 |
| Male | 19 |
| Ethnicity (NIH/OMB)(Participants) | Transnasal Thermal Regulating Device |
|---|---|
| Hispanic or Latino | 4 |
| Not Hispanic or Latino | 26 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Transnasal Thermal Regulating Device |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 16 |
| White | 9 |
| More than one race | 0 |
| Unknown or Not Reported | 4 |
| Region of Enrollment(participants) | Transnasal Thermal Regulating Device |
|---|---|
| United States | 30 |
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This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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