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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03053258

Acronym

VAP-VOC

Enrollment

Registered

2017-02-15

Start date

2016-10-31

Completion date

2019-02-28

Last updated

2019-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial Infections

Brief 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.

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.

Interventions

DEVICECollection of exhaled breath sample

Collect exhaled breath sample from patients with suspected VAP

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Diagnostic Breath Analysis	6 months	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026