Sepsis, Severe Sepsis and Septic Shock Detection by Breath Analysis

Landon Pediatric Foundation

Status: Completed

Conditions: Sepsis

Treatments: Device: Breath sample collection

Study type: Interventional

Funder types: Other

Identifiers

NCT03497182

Study 177: ZNose

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Breath sample collection

Experimental group

Treatment:

Device: Breath sample collection