Sepsis, Severe Sepsis and Septic Shock Detection by Breath Analysis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-02

Study Completion Date

2018-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Sepsis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Breath sample collection

Group Type EXPERIMENTAL

Breath sample collection

Intervention Type DEVICE

Subject exhales into breath collection container.

Interventions

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Breath sample collection

Subject exhales into breath collection container.

Intervention Type DEVICE

Eligibility Criteria

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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