Sepsis, Severe Sepsis and Septic Shock Detection by Breath Analysis

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03497182
• Other study ID #: Study 177: ZNose
• Status: Completed
• Phase: N/A
• Start date: May 2, 2017
• Est. completion date: October 31, 2018

Study information

• Verified date: May 2019
• Source: Landon Pediatric Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: October 31, 2018
• Est. primary completion date: October 6, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sepsis
• Shock, Septic
• Toxemia

Intervention

Device:
• Breath sample collection
Subject exhales into breath collection container.

Locations

Country	Name	City	State
United States	Ventura County Medical Center	Ventura	California

Sponsors (1)

Lead Sponsor	Collaborator
Landon Pediatric Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	five minutes