Diagnostic Breath Analysis Study to Detect Sepsis
Pilot Study to Evaluate Diagnostic Breath Analysis for Early Detection of Systemic Inflammatory Response Syndrome (SIRS) and Sepsis
1 other identifier
observational
10
1 country
1
Brief Summary
Analysis of exhaled breath samples using a high-speed gas chromatography medical device will identify Volatile Organic Compounds (VOC) that are specifically associated with SIRS and Sepsis. Primary outcome measures will include the assessment of the zNose Diagnostic Breath Analysis System, which includes high-speed gas chromatography, in the early detection of SIRS and Sepsis as compared with current SIRS and Sepsis evaluation methods.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2015
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 24, 2015
CompletedFirst Posted
Study publicly available on registry
August 26, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedSeptember 8, 2016
September 1, 2016
3 months
August 24, 2015
September 7, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Diagnostic Breath Analysis
Diagnostic Breath Analysis to identify Volatile Organic Compounds (VOC) associated with Sepsis and SIRS
6 months
Study Arms (1)
Diagnostic Breath Analysis
Patients at risk of SIRS
Interventions
Eligibility Criteria
Patients enter through Emergency Room, are identified at risk for SIRS
You may qualify if:
- Age 18 years of age or older
- Able to give written and dated informed consent prior to any study specific procedures.
- Able to follow instructions for specific breathing maneuvers.
- Able to breath into a medical grade tube, vial or bag.
- Initial assessment and screening indicates SIRS or Sepsis.
You may not qualify if:
- Cognitively impaired and unable to complete informed consent documents.
- Unable to follow instructions during testing.
- Severe dyspnea.
- Use of supplement oxygen which cannot be discontinued during testing.
- Unable to perform breathing maneuvers required to provide multiple breath samples.
- Swallowing disorders or chronic aspiration.
- History of pneumothorax.
- Patients requiring mechanical ventilation
- Patients who are pregnant.
- Patients who have smoked cigarettes or cigars within 30 days prior to trial admission.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ventura County Medical Center
Ventura, California, 93003, United States
Biospecimen
Exhaled breath saved for re-test in thirty days
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Crhis Landon, MD
Ventura County Medical Center
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2015
First Posted
August 26, 2015
Study Start
June 1, 2015
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
September 8, 2016
Record last verified: 2016-09