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Changes in Exhaled 13CO2/12CO2 Breath Delta Value as an Early Indicator of Infection in ICU Patients

NCT02327130 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2019-01-03

Study results available
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Summary

Carbon-12 and carbon-13 are naturally-abundant isotopes in exhaled breath carbon dioxide. The ratio of carbon-13 to carbon-12 in exhaled breath is known as the breath delta value (BDV). This study is seeking to determine if the breath delta value of critically ill adults is an early indicator of the onset of infection that may lead to sepsis.

Conditions

Interventions

DEVICE

Isomark Canary™

Isomark, LLC is a Madison, Wisconsin-based company that has developed an investigational device, the Isomark Canary™, that is intended to determine the breath delta value of breath samples collected from critically ill patients.

Sponsors & Collaborators

  • University of Florida

    collaborator OTHER

  • Ohio State University

    collaborator OTHER

  • Washington University School of Medicine

    collaborator OTHER

  • University of Colorado, Denver

    collaborator OTHER

  • Isomark, LLC

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02327130 on ClinicalTrials.gov