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Sepsis, Severe Sepsis and Septic Shock Detection by Breath Analysis

Study to Assess Feasibility of Sepsis, Severe Sepsis and Septic Shock Detection by Breath Analysis

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03497182
Enrollment
45
Registered
2018-04-13
Start date
2017-05-02
Completion date
2018-10-31
Last updated
2019-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis

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.

Interventions

Subject exhales into breath collection container.

Sponsors

Landon Pediatric Foundation
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Volatile Organic Compound (VOC) Patternfive minutesDetection 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026