Back to resultsSepsis, Severe Sepsis and Septic Shock Detection by Breath Analysis
Primary Purpose
Sepsis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Breath sample collection
Sponsored by
About this trial
This is an interventional diagnostic trial for Sepsis
Eligibility Criteria
Inclusion Criteria:
- admitted to Emergency Department
- suspected of sepsis according to hospital screening criteria; point of care blood lactate test performed
- age 18 or older
Exclusion Criteria:
- member of Vulnerable Patient Population
- unable to complete Patient Informed Consent process/document
Sites / Locations
- Ventura County Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Breath sample collection
Arm Description
Outcomes
Primary Outcome Measures
Volatile Organic Compound (VOC) Pattern
Detection of a unique pattern of Volatile Organic Compounds (VOCs) in the breath samples of patients confirmed as having sepsis/severe sepsis/septic shock differentiated from subjects confirmed as not septic.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03497182
Brief Title
Sepsis, Severe Sepsis and Septic Shock Detection by Breath Analysis
Official Title
Study to Assess Feasibility of Sepsis, Severe Sepsis and Septic Shock Detection by Breath Analysis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
May 2, 2017 (Actual)
Primary Completion Date
October 6, 2018 (Actual)
Study Completion Date
October 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Landon Pediatric Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Breath samples will be collected from patients suspected of sepsis/severe sepsis or septic shock according to hospital sepsis screening criteria in the Emergency Department.
Detailed Description
Breath samples will be collected from patients suspected of sepsis that meet the criteria in the hospital's Sepsis Patient Management Protocol for blood lactate point of care testing. The breath samples will be collected from the patient by the Respiratory Therapist (RT) at the time of blood sample collection for the blood lactate test.
The breath samples will be analyzed via gas chromatography-surface acoustic wave spectroscopy for detection of a pattern of volatile organic compounds (VOCs). Multivariate analysis will be performed on breath sample data to determine feasibility of associating a unique VOC pattern with septic/severe septic/septic shock patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Breath sample collection
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Breath sample collection
Intervention Description
Subject exhales into breath collection container.
Primary Outcome Measure Information:
Title
Volatile Organic Compound (VOC) Pattern
Description
Detection of a unique pattern of Volatile Organic Compounds (VOCs) in the breath samples of patients confirmed as having sepsis/severe sepsis/septic shock differentiated from subjects confirmed as not septic.
Time Frame
five minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
admitted to Emergency Department
suspected of sepsis according to hospital screening criteria; point of care blood lactate test performed
age 18 or older
Exclusion Criteria:
member of Vulnerable Patient Population
unable to complete Patient Informed Consent process/document
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris Landon
Organizational Affiliation
Director Pediatrics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ventura County Medical Center
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Sepsis, Severe Sepsis and Septic Shock Detection by Breath Analysis
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