Diagnostic Breath Analysis Study to Detect Sepsis

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.

Inclusion criteria

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.

Exclusion criteria

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.