POMCO2 Clinical Study MicroTrend System pCO2 Sensor

ExoStat Medical, Inc.7 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Hypoperfusion

Interventions

MicroTrend SystemDEVICE

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.

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Hospitalized adult (age 22 years and older) in the critical care unit 2. Willing and able to provide independent written informed consent (or the patient's legal representative, if applicable) 3. Willing and physically able to comply with the study protocol and procedures Exclusion Criteria: 1. 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 2. Any clinically significant medical health history or vital sign deemed by the investigator to potentially interfere with study conduct 3. Vulnerable subject populations (e.g., incarcerated or cognitively challenged adults)

Locations (1)

Captain James A. Lovell Federal Health Care Center

North Chicago, Illinois, United States

Outcomes

Primary Outcomes

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

Time frame: 4-6 hours

Data from ClinicalTrials.gov

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