Diagnostic Breath Analysis Study to Detect Sepsis

September 7, 2016 updated by: Landon Pediatric Foundation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Ventura, California, United States, 93003
        • Ventura County Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients enter through Emergency Room, are identified at risk for SIRS

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Diagnostic Breath Analysis
Patients at risk of SIRS
Device: Diagnostic Breath Analysis
Conduct exhaled breath samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic Breath Analysis
Time Frame: 6 months
Diagnostic Breath Analysis to identify Volatile Organic Compounds (VOC) associated with Sepsis and SIRS
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Landon Pediatric Foundation

Investigators

  • Principal Investigator: Crhis Landon, MD, Ventura County Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

August 24, 2015

First Submitted That Met QC Criteria

August 25, 2015

First Posted (Estimate)

August 26, 2015

Study Record Updates

Last Update Posted (Estimate)

September 8, 2016

Last Update Submitted That Met QC Criteria

September 7, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Study:177

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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