POMCO2 Clinical Study MicroTrend System pCO2 Sensor

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Safety & Efficacy of Oral Mucosal Carbon Dioxide Pressure (POMCO2) Measurement to Monitor Tissue Perfusion

Conditions
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Hypoperfusion

Intervention / Treatment
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* Device: MicroTrend System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hospitalized adult (age 22 years and older) in the critical care unit Willing and able to provide independent written informed consent (or the patient's legal representative, if applicable) Willing and physically able to comply with the study protocol and procedures Exclusion Criteria: Evidence of intra- or peri-oral, buccal, or gingival disease or trauma to the face or mouth that may interfere with MicroTrend System that is deemed clinically significant by the investigator Any clinically significant medical health history or vital sign deemed by the investigator to potentially interfere with study conduct Vulnerable subject populations (e.g., incarcerated or cognitively challenged adults)

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MicroTrend System<br>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. | Device: MicroTrend System<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral mucosal carbon dioxide pressure