POMCO2 Clinical Study MicroTrend System pCO2 Sensor

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05499624

Enrollment

Registered

2022-08-12

Start date

2022-11-22

Completion date

2023-01-09

Last updated

2023-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoperfusion

Keywords

Oral mucosal carbon dioxide pressure

Brief summary

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

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.

Interventions

DEVICEMicroTrend System

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

22 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Correlation between POMCO2	4-6 hours	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026