POMCO2 Clinical Study MicroTrend System pCO2 Sensor

Not Applicable

Terminated

• Conditions: Hypoperfusion
• Interventions: Device: MicroTrend System

• Registration Number: NCT05499624
• Lead Sponsor: ExoStat Medical, Inc.

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.

Study Timeline

• Study First Submitted: 2022-08-10
• Study First Submitted QC: 2022-08-11
• Study First Posted: 2022-08-12
• Study Start: 2022-11-22
• Primary Completion: 2023-01-09
• Study Completion: 2023-01-09
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-08
• Last Update Posted: 2023-03-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MicroTrend System	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Captain James A. Lovell Federal Health Care Center; 🇺🇸 North Chicago, Illinois, United States