Diagnostic Breath Analysis Study to Detect Sepsis

NCT ID: NCT02532959

Last Updated: 2016-09-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2015-09-30

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.

Conditions

Puerperal: [Major Infection] or [Sepsis]

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Diagnostic Breath Analysis

Patients at risk of SIRS

Diagnostic Breath Analysis

Intervention Type: DEVICE

Conduct exhaled breath samples

Interventions

Diagnostic Breath Analysis

Conduct exhaled breath samples

Intervention Type: DEVICE

Eligibility 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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Landon Pediatric Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Crhis Landon, MD

Role: PRINCIPAL_INVESTIGATOR

Ventura County Medical Center

Locations

Ventura County Medical Center

Ventura, California, United States

Countries

United States

Other Identifiers

Study:177

Identifier Type: -

Identifier Source: org_study_id