Diagnostic Breath Analysis Study to Detect Sepsis
Completed
Conditions studied: Puerperal: [Major Infection] or [Sepsis]
In brief
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.
Key facts
- Study ID
- NCT02532959
- Run by
- Landon Pediatric Foundation
- People needed
- 10
- Starts
- 2015-06-01
- Expected to finish
- 2015-09-01
- Last updated by the study team
- 2016-09-08
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Inclusion Criteria
- 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…
- Exclusion Criteria
- 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.
Where it is running
- Ventura County Medical Center — Ventura, California, United States
Full record on ClinicalTrials.gov
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