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Trial record 25 of 33704 for:    value

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

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ClinicalTrials.gov Identifier: NCT02327130
Recruitment Status : Completed
First Posted : December 30, 2014
Results First Posted : January 3, 2019
Last Update Posted : January 3, 2019
Sponsor:
Collaborators:
University of Florida
Ohio State University
Washington University School of Medicine
University of Colorado, Denver
Information provided by (Responsible Party):
Isomark, LLC

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Sepsis
Intervention Device: Isomark Canary™
Enrollment 32
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Isomark Canary
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 32
Completed 20
Not Completed 12
Reason Not Completed
Discharged in less than 5 days             5
Physician Decision             2
Unable to provide breath sample             1
Incorrectly place ventilator adaptor             1
Met exclusion criteria             3
Arm/Group Title Critically Ill Subjects at Risk for Infection
Hide Arm/Group Description Critically ill adult ICU subjects who are not suspected of having an infection at the time of ICU admission were enrolled as study subjects.
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
<=18 years
0
   0.0%
Between 18 and 65 years
15
  75.0%
>=65 years
5
  25.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
7
  35.0%
Male
13
  65.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Hispanic or Latino
1
   5.0%
Not Hispanic or Latino
18
  90.0%
Unknown or Not Reported
1
   5.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
3
  15.0%
White
16
  80.0%
More than one race
0
   0.0%
Unknown or Not Reported
1
   5.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants
20
1.Primary Outcome
Title Change in Breath Delta Value
Hide Description 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.
Time Frame Baseline to ICU discharge or 7 days, whichever came first
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Exhaled Breath
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 20
Mean (Standard Error)
Unit of Measure: parts per mil (‰)
0.44  (1.09)
2.Secondary Outcome
Title Number of Participants With an Infection Diagnosis
Hide Description Daily analysis infection status from blood samples given from each participant.
Time Frame Days 1 through 7
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Infection Diagnosis
Hide Arm/Group Description:
An endpoint adjudication committee (EAC), composed of three independent senior infectious disease experts, not involved in the subject clinical care, reviewed each study subjects’ data to determine the clinical time and date of infection. Each EAC member independently reviewed the subject cases and completed the EAC Infection Status case report form. In cases where an infection developed the EAC placed a time and date stamp for time of first suspicion of infection and confirmation based on clinical judgement culture, or diagnostic imaging.
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: Participants
11
3.Other Pre-specified Outcome
Title Positive and Negative Predictive Value of BDV for Infection Diagnosis
Hide Description

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'.

Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sensitivity Specificity
Hide Arm/Group Description:
Percent sensitivity for BDV to predict an infection
Percent specificity for BDV to predict an infection
Overall Number of Participants Analyzed 20 20
Measure Type: Number
Unit of Measure: percent
90.1 66.7
Time Frame 10 days per subject, throughout enrollment period April 2015 to December 2017.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title At Risk for Infection
Hide Arm/Group Description All subjects were enrolled were at risk for developing infections during the study but did not currently exhibit signs of ongoing infection.
All-Cause Mortality
At Risk for Infection
Affected / at Risk (%)
Total   0/20 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
At Risk for Infection
Affected / at Risk (%)
Total   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
At Risk for Infection
Affected / at Risk (%)
Total   0/20 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Daniel Butz, Chief Scientific Officer
Organization: Isomark, LLC
Phone: (608) 561-1895
EMail: daniel.butz@isomark.com
Layout table for additonal information
Responsible Party: Isomark, LLC
ClinicalTrials.gov Identifier: NCT02327130     History of Changes
Obsolete Identifiers: NCT02258022
Other Study ID Numbers: Canary01
First Submitted: December 23, 2014
First Posted: December 30, 2014
Results First Submitted: October 11, 2018
Results First Posted: January 3, 2019
Last Update Posted: January 3, 2019