Diagnostic Breath Analysis Study to Detect Sepsis

Puerperal: [Major Infection] or [Sepsis] Clinical Trial

Official title:

Pilot Study to Evaluate Diagnostic Breath Analysis for Early Detection of Systemic Inflammatory Response Syndrome (SIRS) and Sepsis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02532959
• Other study ID #: Study:177
• Status: Completed
• Phase: N/A
• First received: August 24, 2015
• Last updated: September 7, 2016
• Start date: June 2015
• Est. completion date: September 2015

Study information

• Verified date: September 2016
• Source: Landon Pediatric Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Puerperal: [Major Infection] or [Sepsis]
• Sepsis
• Systemic Inflammatory Response Syndrome
• Toxemia

Intervention

Device:
• Diagnostic Breath Analysis
Conduct exhaled breath samples

Locations

Country	Name	City	State
United States	Ventura County Medical Center	Ventura	California

Sponsors (1)

Lead Sponsor	Collaborator
Landon Pediatric Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic Breath Analysis	Diagnostic Breath Analysis to identify Volatile Organic Compounds (VOC) associated with Sepsis and SIRS	6 months