POMCO2 Clinical Study MicroTrend System pCO2 Sensor

ExoStat Medical

Status: Terminated

Conditions: Hypoperfusion

Treatments: Device: MicroTrend System

Study type: Interventional

Funder types: Industry

Identifiers

NCT05499624

EXO-CL-5000

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7 patients

Sex: All

Ages: 22+ years old

Volunteers: No 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)

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

MicroTrend System

Experimental group

Description:

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.

Treatment:

Device: MicroTrend System