POMCO2 Clinical Study MicroTrend System pCO2 Sensor

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-22

Study Completion Date

2023-01-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Effect of Wearing Masks on End-tidal Carbon Dioxide and Pulse Oximetry

NCT05114993

Carbon Dioxide

COMPLETED NA

The Feasibility and Accuracy of Exhaled CO2 to Measure Cardiac Output in Ventilated Patients Without Tracheal Intubation

NCT00783679

Cardiac Physiology Cardiac Output

WITHDRAWN NA

mCVI® Lighting Conditions Clinical Study

NCT04811300

Algorithm Verification

COMPLETED

mCVI Confirmatory Clinical Study: Algorithm Verification

NCT04692064

Algorithm Verification

COMPLETED

SpO2 Accuracy Validation of the OxySoft Sensor Via Reference CO-Oximetry Motion Study

NCT04559763

Hypoxia Desaturation of Blood

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypoperfusion

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MicroTrend System

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.

Group Type EXPERIMENTAL

MicroTrend System

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MicroTrend 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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No