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

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

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.

Study Overview

• Status: Completed
• Conditions: Bacterial Infections
• Intervention / Treatment: Device: Collection of exhaled breath sample

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• United States
  • California
    • Ventura, California, United States, 93003
      • Ventura County Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Mechanically ventilated patients with suspected VAP infection

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Diagnostic Breath Analysis: VAP; Collection of exhaled breath samples	Device: Collection of exhaled breath sample; Collect exhaled breath sample from patients with suspected VAP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Landon Pediatric Foundation
• Investigators: Principal Investigator: Chris Landon, MD, Ventura County Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): February 1, 2019

Study Registration Dates

• First Submitted: February 9, 2017
• First Submitted That Met QC Criteria: February 10, 2017
• First Posted (Actual): February 15, 2017

Study Record Updates

• Last Update Posted (Actual): May 7, 2019
• Last Update Submitted That Met QC Criteria: May 3, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Bacterial Infections and Mycoses; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Pneumonia; Bacterial Infections; Pneumonia, Ventilator-Associated
• Other Study ID Numbers: Study 177 ZNose

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO