Clinical trial NCT02532959: Diagnostic Breath Analysis Study to Detect Sepsis
Official title: Pilot Study to Evaluate Diagnostic Breath Analysis for Early Detection of Systemic Inflammatory Response Syndrome (SIRS) and Sepsis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Puerperal: [Major Infection] or [Sepsis]
Lead sponsor: Landon Pediatric Foundation
Sponsor class: OTHER
First posted: 2015-08-26
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients enter through Emergency Room, are identified at risk for SIRS

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Diagnostic Breath Analysis
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ventura
country: United States
facility: Ventura County Medical Center
state: California
Study officials:
affiliation: Ventura County Medical Center
name: Crhis Landon, MD
role: PRINCIPAL_INVESTIGATOR
References: