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Completed

NCT Number: NCT03053258

Diagnostic Breath Analysis for 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ventura County Medical Center

Ventura, California, 93003, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients ≥ 48 hours of ventilation with suspected VAP infection. Suspicion of VAP infection based on clinical evaluation criteria:
  • Three or more positive out of the following:
  • Tympanic temperature > 38 °C or < 35.5 °C
  • Blood leukocytosis (10,000/µl)
  • More than ten leukocytes in Gram stain of tracheal aspirate (in high-flow field)
  • Positive culture of tracheal aspirate
  • 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.

Treatment and study plan

Collection of exhaled breath sample

Device

Collect exhaled breath sample from patients with suspected VAP

Primary outcomes

  1. Diagnostic Breath Analysis

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Landon Pediatric Foundation

Other

Registry information

Official study title

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

Acronym: VAP-VOC

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Feb 15, 2017
Registry last updated
May 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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