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| Name | Class |
|---|---|
| Bright Research Partners | INDUSTRY |
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The objective of this non-significant risk (NSR) study is to evaluate the safety and efficacy of the MicroTrend System by correlating POMCO2 data with relevant clinical metrics including arterial pressure and heart rate.
This is a prospective, single-center, non-randomized, non-significant risk (NSR) study evaluating the safety and efficacy of the MicroTrend System, which is indicated for monitoring oral mucosal carbon dioxide pressure (POMCO2) in hospital patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MicroTrend System | Experimental | MicroTrend System is placed onto the subject's cheek and the subject will actively participate in the study for up to 6 hours, with up to 4 hours of sensor monitoring. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MicroTrend System | Device | The hands-free device measures oral mucosal carbon dioxide pressure (POMCO2) and functions outside of the body and does not require a surgical procedure or any significant deviation from standard practice to operate. |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between POMCO2 | Assessed by the MicroTrend System and the relevant clinical metrics of mean arterial pressure and heart rate. Statistically significant correlations (defined as p < 0.05) will be deemed success for this purpose, with adjustment for multiplicity by the Hochberg-Holm method | 4-6 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raul J Gazmuri, MD, PhD | Captain James A. Lovell Federal Health Care Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Captain James A. Lovell Federal Health Care Center | North Chicago | Illinois | 60064 | United States |
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