NCT03497182

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Landon Pediatric Foundation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sepsis

Interventions

Type	Name	Description
DEVICE	Breath sample collection	Subject exhales into breath collection container.

Timeline

• Start date: 2017-05-02
• Primary completion: 2018-10-06
• Completion: 2018-10-31
• First posted: 2018-04-13
• Last updated: 2019-05-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study