Diagnostic Breath Analysis Study to Detect Sepsis

Completed

• Conditions: Puerperal: [Major Infection] or [Sepsis]
• Interventions: Device: Diagnostic Breath Analysis

• Registration Number: NCT02532959
• Lead Sponsor: Landon Pediatric Foundation

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.

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-08-24
• Study First Submitted QC: 2015-08-25
• Study First Posted: 2015-08-26
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-07
• Last Update Posted: 2016-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diagnostic Breath Analysis	Diagnostic Breath Analysis	Patients at risk of SIRS

Primary Outcome Measures

Name	Time	Method
Diagnostic Breath Analysis	6 months	Diagnostic Breath Analysis to identify Volatile Organic Compounds (VOC) associated with Sepsis and SIRS

Trial Locations

Locations (1)

Ventura County Medical Center; 🇺🇸 Ventura, California, United States