Diagnostic Breath Analysis for Detection of Ventilator Acquired Pneumonia (VAP)

Bacterial Infections Clinical Trial

— VAP-VOC  

Official title:

Pilot Study to Evaluate Diagnostic Breath Analysis for Early Detection of Ventilator Acquired Pneumonia (VAP)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03053258
• Other study ID #: Study 177 ZNose
• Status: Completed
• Start date: October 2016
• Est. completion date: February 2019

Study information

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

Clinical Trial Summary

Breath samples from patients with Ventilator Acquired Pneumonia (VAP) will be analyzed to identify Volatile Organic Compounds (VOC) that have been specifically associated with VAP in previous animal models.

Primary outcome measures will include the assessment of the zNose Diagnostic Breath Analysis System in the early detection of VOC's associated with VAP.

Description:

On clinical suspicion of VAP, breath samples will be collected from the expiratory limb of the patient's ventilator tubing circuit. A sterile Tedlar collection bag will be used to connect to the sample port and collect the breath sample. The expiratory limb sample port will be utilized to ensure maintenance of the integrity of the ventilator circuitry. The breath samples will be analyzed via the ZNose breath analysis system.

Immediately following collection of breath samples, bronchoalveolar lavage fluid (BALF) will be collected and subjected to bacteriology testing for confirmation of VAP-positive and VAP-negative patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 2019
• Est. primary completion date: October 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients = 48 hours of ventilation with suspected VAP infection. Suspicion of VAP infection based on clinical evaluation criteria:

1. Three or more positive out of the following:

1. Tympanic temperature > 38 °C or < 35.5 °C

2. Blood leukocytosis (10,000/µl)

3. More than ten leukocytes in Gram stain of tracheal aspirate (in high-flow field)

4. Positive culture of tracheal aspirate

2. New, persistent, or progressive infiltrate on chest radiograph

Exclusion Criteria:

Patients with pre-existing structural lung disease (COPD, asthma, lung cancer, etc.), thrombocytopenia (< 40,000/µL) and other coagulation abnormalities.

Related Conditions & MeSH terms

• Bacterial Infections
• Pneumonia
• Pneumonia, Ventilator-Associated

Intervention

Device:
• Collection of exhaled breath sample
Collect exhaled breath sample from patients with suspected VAP

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	Diagnostic Breath Analysis	Diagnostic analysis of Volatile Organic Compounds in exhaled breath samples These are compared to known compounds associated with sepsis in exhaled breath in septic rats, such as the oliphenones.	6 months