POMCO2 Clinical Study MicroTrend System pCO2 Sensor

Hypoperfusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05499624
• Other study ID #: EXO-CL-5000
• Status: Terminated
• Phase: N/A
• Start date: November 22, 2022
• Est. completion date: January 9, 2023

Study information

• Verified date: March 2023
• Source: ExoStat Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: January 9, 2023
• Est. primary completion date: January 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hypoperfusion

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Captain James A. Lovell Federal Health Care Center	North Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
ExoStat Medical, Inc.	Bright Research Partners

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	4-6 hours