Ventilator Associated Pneumonia (VAP)NCT02652247
Serial, Non-invasive Analysis of Exhaled Breath Condensate in Ventilated Trauma Patients
A study testing molecular analysis of exhaled breath condensate, molecular analysis of mini-bronchoalveolar lavage (BAL) aspirate and molecular analysis of bronchoalveolar lavage (BAL) aspirate in people with Ventilator Associated Pneumonia (VAP), run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
To determine if the analysis of exhaled breath condensate correlates with the development \& resolution of pneumonia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator Associated Pneumonia (VAP)
- What is being tested?
- molecular analysis of exhaled breath condensate, molecular analysis of mini-bronchoalveolar lavage (BAL) aspirate and molecular analysis of bronchoalveolar lavage (BAL) aspirate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Jun 2022
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Admitted to the Vanderbilt Trauma (TICU) and Surgical Intensive Care Units (SICU)
- Mechanically ventilated for ≥2 successive days (without planned extubation within 24 hours of enrollment)
Who cannot join
- Less than 18 years of age
- Expected survival less than 24 hours
- Anticipated extubation within 24 hours of enrollment
- Conditions limiting the subject's ability to tolerate collection of lavage specimens, including: FIO2 > 80%; PEEP > 16 cmH2O; Intracranial pressure >20 cmH2O; Tracheal or mucosal bleeding; Platelet count < 20,000 cells/uL; INR > 2.0
- Known prisoners
- Pneumonia diagnosis at the time of ICU admission
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Serial, Non-invasive Molecular Analysis of Exhaled Breath Condensate to Define the Pulmonary Flora in Critically Injured, Ventilated Adults: The Clinical Trial
To determine if the analysis of exhaled breath condensate correlates with the development \& resolution of pneumonia.
Read the detailed description
This proposal investigates the utility of exhaled breath condensate fluid (EBCF) collected from heat moisture exchange (HME) filters connected to patient's endotracheal tubes for early, non-invasive detection of ventilator-associated pneumonia (VAP) in critically ill or injured ICU patients. The development of pneumonia during mechanical ventilation is the most common healthcare-associated infection in severely injured patients, accounting for substantial morbidity, excess ICU and hospital stay, additional cost and increased mortality.
- Conditions
- Ventilator Associated Pneumonia (VAP)
- Being tested
- molecular analysis of exhaled breath condensate, molecular analysis of mini-bronchoalveolar lavage (BAL) aspirate, molecular analysis of bronchoalveolar lavage (BAL) aspirate
- Keywords
- trauma, ventilator, surgical ICU
- Medical subject headings
- Pneumonia, Ventilator-Associated, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
molecular analysis of exhaled breath condensateProcedure or surgery
molecular analysis of mini-bronchoalveolar lavage (BAL) aspirateProcedure or surgery
molecular analysis of bronchoalveolar lavage (BAL) aspirateProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| ventilated trauma patients with pneumonia | Experimental | ventilated trauma patients with pneumonia Receives: Procedure: molecular analysis of exhaled breath condensate; Procedure: molecular analysis of mini-bronchoalveolar lavage (BAL) aspirate; Procedure: molecular analysis of bronchoalveolar lavage (BAL) aspirate |
| ventilated trauma patients without pneumonia | Experimental | ventilated trauma patients without pneumonia Receives: Procedure: molecular analysis of exhaled breath condensate; Procedure: molecular analysis of mini-bronchoalveolar lavage (BAL) aspirate |
| ventilated surgical ICU patients with pneumonia | Experimental | ventilated surgical ICU patients with pneumonia Receives: Procedure: molecular analysis of exhaled breath condensate; Procedure: molecular analysis of mini-bronchoalveolar lavage (BAL) aspirate; Procedure: molecular analysis of bronchoalveolar lavage (BAL) aspirate |
| ventilated surgical ICU patients without pneumonia | Experimental | ventilated surgical ICU patients without pneumonia Receives: Procedure: molecular analysis of exhaled breath condensate; Procedure: molecular analysis of mini-bronchoalveolar lavage (BAL) aspirate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients with a positive association between the exhaled breath condensate fluid and BAL fluid in in patients suspected of pneumonia.
To determine the association between the microbial community in both EBCF specimens and bronchoalveolar lavage fluid (BALF) samples in critically ill and injured, mechanically ventilated patients suspected of VAP.
Measured: enrollment to hospital day 15
The per cent of positive correlation for the development & resolution of pneumonia based on changes in bacteria found in the exhaled breath condensate.
To develop a robust predictive model for the development of VAP and its resolution based on changes in the microbial community in EBCF collected over the course of ventilation.
Measured: enrollment to hospital day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionJun 2022
- Study completionJun 2022
Why it stopped: We did not have the funding to complete the study enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator Associated Pneumonia (VAP)Studies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Principal investigator, Wonder Drake, Vanderbilt University Medical Center
- Investigators
- Addison K May, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02652247
- Sponsor's protocol ID
- 151194
- Other IDs
- 1R01GM115353-01
- Status last verified
- Aug 2022
- First submitted
- 7 Jan 2016
- Last updated
- 4 Aug 2022
- 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 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serial, Non-invasive Molecular Analysis of Exhaled Breath Condensate to Define the Pulmonary Flora in Critically Injured, Ventilated Adults: The Clinical Trial
- ClinicalTrials.gov ID
- NCT02652247
- Acronym / sponsor ID
- 151194
- Conditions
- Ventilator Associated Pneumonia (VAP)
- Keywords
- trauma, ventilator, surgical ICU
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: We did not have the funding to complete the study enrollment.
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- Jan 2016
- Primary completion
- Jun 2022 (actual)
- Study completion
- Jun 2022 (actual)
- First posted
- 11 Jan 2016 (estimated)
- 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.
To determine if the analysis of exhaled breath condensate correlates with the development \& resolution of pneumonia.
Detailed description
This proposal investigates the utility of exhaled breath condensate fluid (EBCF) collected from heat moisture exchange (HME) filters connected to patient's endotracheal tubes for early, non-invasive detection of ventilator-associated pneumonia (VAP) in critically ill or injured ICU patients. The development of pneumonia during mechanical ventilation is the most common healthcare-associated infection in severely injured patients, accounting for substantial morbidity, excess ICU and hospital stay, additional cost and increased mortality.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ventilated trauma patients with pneumonia | Experimental | Procedure: molecular analysis of exhaled breath condensate, Procedure: molecular analysis of mini-bronchoalveolar lavage (BAL) aspirate, Procedure: molecular analysis of bronchoalveolar lavage (BAL) aspirateventilated trauma patients with pneumonia |
| ventilated trauma patients without pneumonia | Experimental | Procedure: molecular analysis of exhaled breath condensate, Procedure: molecular analysis of mini-bronchoalveolar lavage (BAL) aspirateventilated trauma patients without pneumonia |
| ventilated surgical ICU patients with pneumonia | Experimental | Procedure: molecular analysis of exhaled breath condensate, Procedure: molecular analysis of mini-bronchoalveolar lavage (BAL) aspirate, Procedure: molecular analysis of bronchoalveolar lavage (BAL) aspirateventilated surgical ICU patients with pneumonia |
| ventilated surgical ICU patients without pneumonia | Experimental | Procedure: molecular analysis of exhaled breath condensate, Procedure: molecular analysis of mini-bronchoalveolar lavage (BAL) aspirateventilated surgical ICU patients without pneumonia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 or older
- Admitted to the Vanderbilt Trauma (TICU) and Surgical Intensive Care Units (SICU)
- Mechanically ventilated for ≥2 successive days (without planned extubation within 24 hours of enrollment)
Key exclusion criteria (6 listed)
- Less than 18 years of age
- Expected survival less than 24 hours
- Anticipated extubation within 24 hours of enrollment
- Conditions limiting the subject's ability to tolerate collection of lavage specimens, including: FIO2 > 80%; PEEP > 16 cmH2O; Intracranial pressure >20 cmH2O; Tracheal or mucosal bleeding; Platelet count < 20,000 cells/uL; INR > 2.0
- Known prisoners
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 |
|---|---|---|
| molecular analysis of exhaled breath condensate | Procedure or surgery | ventilated surgical ICU patients with pneumonia, ventilated surgical ICU patients without pneumonia, ventilated trauma patients with pneumonia, ventilated trauma patients without pneumonia |
| molecular analysis of mini-bronchoalveolar lavage (BAL) aspirate | Procedure or surgery | ventilated surgical ICU patients with pneumonia, ventilated surgical ICU patients without pneumonia, ventilated trauma patients with pneumonia, ventilated trauma patients without pneumonia |
| molecular analysis of bronchoalveolar lavage (BAL) aspirate | Procedure or surgery | ventilated surgical ICU patients with pneumonia, ventilated trauma patients with pneumonia |
Primary outcome
The number of patients with a positive association between the exhaled breath condensate fluid and BAL fluid in in patients suspected of pneumonia.
Time frame: enrollment to hospital day 15
To determine the association between the microbial community in both EBCF specimens and bronchoalveolar lavage fluid (BALF) samples in critically ill and injured, mechanically ventilated patients suspected of VAP.
The per cent of positive correlation for the development & resolution of pneumonia based on changes in bacteria found in the exhaled breath condensate.
Time frame: enrollment to hospital day 15
To develop a robust predictive model for the development of VAP and its resolution based on changes in the microbial community in EBCF collected over the course of ventilation.
Results and safety
The study was stopped early (reason given: We did not have the funding to complete the study enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
- Individual participant dataSharing planned: No
Related trials for Ventilator Associated Pneumonia (VAP)
Not yet recruitingObservational study
Early Identification of Pathogens in Children With Respiratory Tract Infection by Mechanical Ventilation Using mNGS
VAP - Ventilator Associated Pneumonia
Recruiting
Immediate Versus Substantiated Antibiotic Therapy in Suspected Non-Severe Ventilator-Associated Pneumonia
Ventilator-Associated Pneumonia (VAP)
Recruiting
Effect of Ventilator Hyperinflation Combined With Body Positioning on ABG in VAP
Ventilator Associated Bacterial Pneumonia (VABP), Critical Illness
Active, not recruiting
HAP/VAP Diagnosis in Critically Ill Septic Patients Using a Multiplex PCR Array
HAP - Hospital Acquired Pneumonia, VAP - Ventilator Associated Pneumonia
RecruitingPhase 4
Combined Use of a Respiratory Multiplex PCR and Algorithm-based Therapy to Improve Early Optimization of Antibiotic Therapy in Critically Ill Patients With Ventilator-associated Pneumonia
Ventilator Associated Pneumonia ( VAP)
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.
Addison K May, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing molecular analysis of exhaled breath condensate, molecular analysis of mini-bronchoalveolar lavage (BAL) aspirate and molecular analysis of bronchoalveolar lavage (BAL) aspirate in people with Ventilator Associated Pneumonia (VAP), run by Vanderbilt University Medical Center 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 3 inclusion and 6 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: stopped early, as of the sponsor's last update on 4 Aug 2022. 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 was stopped early (reason given: We did not have the funding to complete the study enrollment.). Results are not available in the source record.
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?
The number of patients with a positive association between the exhaled breath condensate fluid and BAL fluid in in patients suspected of pneumonia. (time frame: enrollment to hospital day 15). The study lists 2 primary outcomes in all. 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 4 Aug 2022.