Diagnostic Breath Analysis Study to Detect Sepsis
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease, Hospital |
| Therapuetic Areas: | Immunology / Infectious Diseases, Other |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 10/14/2017 |
| Start Date: | June 2015 |
| End Date: | September 2015 |
Pilot Study to Evaluate Diagnostic Breath Analysis for Early Detection of Systemic Inflammatory Response Syndrome (SIRS) and Sepsis
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.
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.
Exhaled breath samples were collected in a Tedlar bag or with a proprietary collection tube.
The collection devices are clean and intended for single-use. They are manufactured with
approved medical grade materials. Patients were asked to breath into a single-use, medical
grade mouthpiece which is connected to the collection bag or tube. The design of the
collection devices does not allow the patient to rebreathe the exhaled gas sample. Patients
enrolled in the clinical study were asked to breathe into the breath collection device for 2
to 4 breaths. Breath collection is completely non-invasive. Breath samples were held for 30
days and retested at the end of the 30 day period to determine if the VOC profile has changed
over time.
The collection devices are clean and intended for single-use. They are manufactured with
approved medical grade materials. Patients were asked to breath into a single-use, medical
grade mouthpiece which is connected to the collection bag or tube. The design of the
collection devices does not allow the patient to rebreathe the exhaled gas sample. Patients
enrolled in the clinical study were asked to breathe into the breath collection device for 2
to 4 breaths. Breath collection is completely non-invasive. Breath samples were held for 30
days and retested at the end of the 30 day period to determine if the VOC profile has changed
over time.
Inclusion Criteria:
Inclusion Criteria
1. Age 18 years of age or older
2. Able to give written and dated informed consent prior to any study specific
procedures.
3. Able to follow instructions for specific breathing maneuvers.
4. Able to breath into a medical grade tube, vial or bag.
5. Initial assessment and screening indicates SIRS or Sepsis.
Exclusion Criteria:
Exclusion Criteria
1. Cognitively impaired and unable to complete informed consent documents.
2. Unable to follow instructions during testing.
3. Severe dyspnea.
4. Use of supplement oxygen which cannot be discontinued during testing.
5. Unable to perform breathing maneuvers required to provide multiple breath samples.
6. Swallowing disorders or chronic aspiration.
7. History of pneumothorax.
8. Patients requiring mechanical ventilation
9. Patients who are pregnant.
10. Patients who have smoked cigarettes or cigars within 30 days prior to trial admission.
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