Bacterial InfectionsVAP-VOCNCT03053258
Diagnostic Breath Analysis for Detection of Ventilator Acquired Pneumonia (VAP)
An observational study of Bacterial Infections, run by Landon Pediatric Foundation at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bacterial Infections
- What is being tested?
- Collection of exhaled breath sample
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Mechanically ventilated patients with suspected VAP infection
Who may be able to join
- 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
Who cannot join
- Patients with pre-existing structural lung disease (COPD, asthma, lung cancer, etc.), thrombocytopenia (< 40,000/µL) and other coagulation abnormalities.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ventura County Medical Center
Ventura, California, 93003
About this study
Official title: 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.
Read the 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.
- Conditions
- Bacterial Infections
- Being tested
- Collection of exhaled breath sample
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of exhaled breath sampleDevice
Collect exhaled breath sample from patients with suspected VAP
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic Breath Analysis: VAP | Collection of exhaled breath samples Receives: Device: Collection of exhaled breath sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2017
- Study startOct 2016
- Primary completionOct 2018
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Landon Pediatric Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chris Landon, MD, Principal investigator, Ventura County Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03053258
- Sponsor's protocol ID
- Study 177 ZNose
- Acronym
- VAP-VOC
- Status last verified
- May 2019
- First submitted
- 9 Feb 2017
- Last updated
- 7 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate Diagnostic Breath Analysis for Early Detection of Ventilator Acquired Pneumonia (VAP)
- ClinicalTrials.gov ID
- NCT03053258
- Acronym / sponsor ID
- VAP-VOC / Study 177 ZNose
- Conditions
- Bacterial Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Landon Pediatric FoundationUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 15 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic Breath Analysis: VAP | – | Device: Collection of exhaled breath sampleCollection of exhaled breath samples |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Mechanically ventilated patients with suspected VAP infection
Key inclusion criteria (7 listed)
- Patients ≥ 48 hours of ventilation with suspected VAP infection. Suspicion of VAP infection based on clinical evaluation criteria:
Key exclusion criteria (1 listed)
- Patients with pre-existing structural lung disease (COPD, asthma, lung cancer, etc.), thrombocytopenia (< 40,000/µL) and other coagulation abnormalities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of exhaled breath sampleCollect exhaled breath sample from patients with suspected VAP | Device | Diagnostic Breath Analysis: VAP |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris Landon, MD principal investigator
Ventura County Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bacterial Infections, run by Landon Pediatric Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Breath Analysis (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2019.