Trial Outcomes & Findings for Changes in Exhaled 13CO2/12CO2 Breath Delta Value as an Early Indicator of Infection in ICU Patients (NCT NCT02327130)

Last Updated: 2019-01-03

Results Overview

The variation in breath delta value was assessed regardless of infection status. Exhaled breath samples were collected from participants upon enrollment and every four hours thereafter until the end of the subject's study duration per protocol. Each subject was used as its own control for the purpose of trend analysis.The first breath sample collected was considered an individual's "baseline" sample. The change in the breath delta value was calculated from this baseline sample.

Recruitment status

COMPLETED

Study phase

Target enrollment

32 participants

Primary outcome timeframe

Baseline to ICU discharge or 7 days, whichever came first

Results posted on

2019-01-03

Participant Flow

Participant milestones

Participant milestones
Measure	Isomark Canary All subjects were enrolled were at risk for developing infections during the study but did not currently exhibit signs of ongoing infection. The 'at risk' enrolled subjects utilized the Isomark Canary to take exhaled breath samples to assess for infection status.
Overall Study STARTED	32
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Isomark Canary All subjects were enrolled were at risk for developing infections during the study but did not currently exhibit signs of ongoing infection. The 'at risk' enrolled subjects utilized the Isomark Canary to take exhaled breath samples to assess for infection status.
Overall Study Discharged in less than 5 days	5
Overall Study Physician Decision	2
Overall Study Unable to provide breath sample	1
Overall Study Incorrectly place ventilator adaptor	1
Overall Study Met exclusion criteria	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Critically Ill Subjects at Risk for Infection n=20 Participants Critically ill adult ICU subjects who are not suspected of having an infection at the time of ICU admission were enrolled as study subjects.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to ICU discharge or 7 days, whichever came first

Outcome measures

Outcome measures
Measure	Exhaled Breath n=20 Participants Exhaled breath samples were collected 6 times per day for 7 days. We will use the Isomark Canary™ to determine the BDV of breath samples collected during this study.	Specificity Percent specificity for BDV to predict an infection
Change in Breath Delta Value	0.44 parts per mil (‰) Standard Error 1.09	—

SECONDARY outcome

Timeframe: Days 1 through 7

Daily analysis infection status from blood samples given from each participant.

Outcome measures

Outcome measures
Measure	Exhaled Breath n=20 Participants Exhaled breath samples were collected 6 times per day for 7 days. We will use the Isomark Canary™ to determine the BDV of breath samples collected during this study.	Specificity Percent specificity for BDV to predict an infection
Number of Participants With an Infection Diagnosis	11 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 7 days

Based on an ROC analysis the optimal cutoff value for indicating the presence of infection using the BDV is 1.4‰. Based on this cutoff value the sensitivity and specificity were calculated. Sensitivity, or the true positive rate, is the proportion of actual positives that are correctly identified. In this case, the sensitivity is the percentage of people who have an infection and were identified by the Isomark Canary as having an 'infection'. The specificity, or the true negative rate, is the promotion of actual negatives that are correctly identified as negative. In this case, the specificity is the proportion of people without infections that were correctly classified by the Isomark Canary as having 'no infection'.

Outcome measures

Outcome measures
Measure	Exhaled Breath n=20 Participants Exhaled breath samples were collected 6 times per day for 7 days. We will use the Isomark Canary™ to determine the BDV of breath samples collected during this study.	Specificity n=20 Participants Percent specificity for BDV to predict an infection
Positive and Negative Predictive Value of BDV for Infection Diagnosis	90.1 percent	66.7 percent

Adverse Events

At Risk for Infection

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Daniel Butz, Chief Scientific Officer

Isomark, LLC

Phone: (608) 561-1895

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place