Diagnostic Breath Analysis for Detection of Ventilator Acquired Pneumonia (VAP)
| Status: | Recruiting |
|---|---|
| Conditions: | Pneumonia, Pneumonia, Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | October 2016 |
| End Date: | February 2019 |
| Contact: | Chris Landon, MD |
| Email: | chris.landon@ventura.org |
| Phone: | (805) 652-6255 |
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.
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.
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.
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.
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.
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