Pneumonia, Ventilator-AssociatedNCT02542553
Bilateral Bronchoalveolar Lavage in Ventilator-associated Pneumonia
A study testing Bilateral BAL in people with Pneumonia, Ventilator-Associated, run by Catholic University of the Sacred Heart.
Trial summary
The purpose of this study is to assess microbiologic concordance rates between right- and left-lung bronchoalveolar lavage cultures from patients with suspected ventilator-associated pneumonia, identify predictors of concordance, and evaluate the impact of discordant microbiology on clinicians' ability to prescribe… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Ventilator-Associated
- What is being tested?
- Bilateral BAL
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- No sites listed yet
- Study dates
- Feb 2013to Jul 2014
- 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
- invasive mechanical ventilation of ≥ 48 hours
- clinically suspected pneumonia (simplified Clinical Pulmonary Infectious Score exceeded 6 or chest radiographs with a new or progressive pulmonary infiltrate in a patient with at least two of the following: purulent respiratory secretions, temperature >38°C or <36°C, white blood cell count >12,000/mm3 or <4,000/mm3)
Who cannot join
- age <18 years
- pregnancy
- absence of informed consent
- an arterial oxygen partial pressure to inspired oxygen fraction ratio (PaO2:FiO2) of ≤150
- use of positive end-expiratory pressure (PEEP) >10 cmH2O
- active uncontrolled bronchospasm
Show all 12Show fewer
- unstable angina or recent (<6 weeks) myocardial infarction
- unstable arrhythmia
- intracranial hypertension
- platelet count ≤20,000/mm3
- international normalized ratio (INR) or activated partial thromboplastin time (aPTT) ratio >1.5
- documented treatment-limitation orders in the patient's chart
About this study
Official title: Bilateral Bronchoalveolar Lavage Cultures for Diagnosing Ventilator-associated Pneumonia. Microbiologic Concordance and Impact on the Efficacy of Treatment Decisions.
The purpose of this study is to assess microbiologic concordance rates between right- and left-lung bronchoalveolar lavage cultures from patients with suspected ventilator-associated pneumonia, identify predictors of concordance, and evaluate the impact of discordant microbiology on clinicians' ability to prescribe appropriate antibiotic treatments, the investigators conducted a prospective observational study in the general intensive care unit of a large university hospital.
Read the detailed description
Bronchoscopic sampling of lower respiratory tract secretions is widely used in intensive care units (ICUs) for the microbiological diagnosis of ventilator-associated pneumonia (VAP). However, the importance of selecting a specific lung segment for sampling is still a matter of debate.
Non-bronchoscopic blind mini-bronchoalveolar lavage (BAL) is currently used for the diagnosis of VAP with satisfactory sensitivity and specificity. In the presence of pneumonia, microbiologic concordance between the left and right lungs becomes crucial. If concordance is low, the reliability of blind sampling becomes questionable.
When the bacterial distribution in the right and left lungs of VAP patients has been investigated using bronchoscopic sampling techniques, rates of microbiological concordance between the two specimens have varied widely (from 53% to 92%). The factors potentially associated with concordant culture yields have never been explored, and it is unclear whether the use of guided, bilateral lung sampling would actually improve the appropriateness of the antibiotic regimens prescribed for patients with suspected VAP.
The primary objective of this study is to assess the frequency of microbiologic concordance between the right- and left-lung samples in ICU patients undergoing bronchoscopic BAL performed with two different fiberoptic bronchoscopes for the suspicion of VAP. Secondary objectives are to identify factors associated with such concordance and to evaluate the suitability of treatments prescribed based on unilateral vs. bilateral BAL cultures.
- Conditions
- Pneumonia, Ventilator-Associated
- Being tested
- Bilateral BAL
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral BALProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Bilateral BAL | Experimental | Bronchoscopies are performed in strict accordance with consensus guidelines. The left or right lung is examined with a flexible fiberoptic bronchoscope. If localized infiltrates are present on the chest radiograph, the tip of the scope is wedged into a subsegment of the area displaying the most marked opacity. In the presence of diffuse opacity or when no clear roentgenographic abnormalities are observed, the tip is positioned in the lingula or right middle lobe. Five 20-ml aliquots of sterile normal saline are then injected and reaspirated with a syringe. Bronchoscopy is then repeated in the same manner in the contralateral lung with a second, sterile bronchoscope of the same brand and model. Receives: Procedure: Bilateral BAL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of microbiologic concordance between the right- and left-lung samples
Pneumonia is microbiologically confirmed when the quantitative culture of one or both BAL specimens is positive at significant growth for at least one potential bacterial pathogen. Right and left BAL cultures are classified as concordant when both are positive for the same organism(s) or when neither show any growth. Cultures are classified as discordant when at least one of the microorganisms isolated from one specimen is not recovered from the contralateral specimen.
Measured: After at least 48 hours of invasive mechanical ventilation
Secondary outcomes (15)
Possible association between purulent secretions and microbiologic concordance between right- and left-lung BAL cultures
Measured: At an expected average of 48 hours after bronchoscopy
Possible association between duration of mechanical ventilation and microbiologic concordance between right- and left-lung BAL cultures
Measured: At an expected average of 48 hours after bronchoscopy
Possible association between duration of ICU stay and microbiologic concordance between right- and left-lung BAL cultures
Measured: At an expected average of 48 hours after bronchoscopy
Possible association between duration of hospital stay and microbiologic concordance between right- and left-lung BAL cultures
Measured: At an expected average of 48 hours after bronchoscopy
Possible association between immunosuppression and microbiologic concordance between right- and left-lung BAL cultures
Measured: At an expected average of 48 hours after bronchoscopy
Possible association between antibiotic treatment and microbiologic concordance between right- and left-lung BAL cultures
Measured: At an expected average of 48 hours after bronchoscopy
Possible association between radiological infiltrate and microbiologic concordance between right- and left-lung BAL cultures
Measured: At an expected average of 48 hours after bronchoscopy
Possible association between body temperature and microbiologic concordance between right- and left-lung BAL cultures
Measured: At an expected average of 48 hours after bronchoscopy
Possible association between WBC count and microbiologic concordance between right- and left-lung BAL cultures
Measured: At an expected average of 48 hours after bronchoscopy
Possible association between PaO2:FiO2 and microbiologic concordance between right- and left-lung BAL cultures
Measured: At an expected average of 48 hours after bronchoscopy
Possible association between PEEP and microbiologic concordance between right- and left-lung BAL cultures
Measured: At an expected average of 48 hours after bronchoscopy
Possible association between CPIS and microbiologic concordance between right- and left-lung BAL cultures
Measured: At an expected average of 48 hours after bronchoscopy
Possible association between type of humidification and microbiologic concordance between right- and left-lung BAL cultures
Measured: At an expected average of 48 hours after bronchoscopy
Possible association between procalcitonin and microbiologic concordance between right- and left-lung BAL cultures
Measured: At an expected average of 48 hours after bronchoscopy
Possible association between C-reactive protein and microbiologic concordance between right- and left-lung BAL cultures
Measured: At an expected average of 48 hours after bronchoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study startFeb 2013
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Pneumonia, Ventilator-AssociatedStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Bello, Catholic University of the Sacred Heart
- Investigators
- Giuseppe Bello, MD, Principal investigator, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02542553
- Sponsor's protocol ID
- Bilateral BAL in VAP
- Status last verified
- Aug 2015
- First submitted
- 25 Aug 2015
- Last updated
- 7 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Meduri GU, Chastre J. The standardization of bronchoscopic techniques for ventilator-associated pneumonia. Chest. 1992 Nov;102(5 Suppl 1):557S-564S. doi: 10.1378/chest.102.5_supplement_1.557s. No abstract available.
PubMed 1424930Marquette CH, Herengt F, Saulnier F, Nevierre R, Mathieu D, Courcol R, Ramon P. Protected specimen brush in the assessment of ventilator-associated pneumonia. Selection of a certain lung segment for bronchoscopic sampling is unnecessary. Chest. 1993 Jan;103(1):243-7. doi: 10.1378/chest.103.1.243.
PubMed 8417887Meduri GU, Reddy RC, Stanley T, El-Zeky F. Pneumonia in acute respiratory distress syndrome. A prospective evaluation of bilateral bronchoscopic sampling. Am J Respir Crit Care Med. 1998 Sep;158(3):870-5. doi: 10.1164/ajrccm.158.3.9706112.
PubMed 9731019Butler KL, Best IM, Oster RA, Katon-Benitez I, Lynn Weaver W, Bumpers HL. Is bilateral protected specimen brush sampling necessary for the accurate diagnosis of ventilator-associated pneumonia? J Trauma. 2004 Aug;57(2):316-22. doi: 10.1097/01.ta.0000088858.22080.cb.
PubMed 15345979Jackson SR, Ernst NE, Mueller EW, Butler KL. Utility of bilateral bronchoalveolar lavage for the diagnosis of ventilator-associated pneumonia in critically ill surgical patients. Am J Surg. 2008 Feb;195(2):159-63. doi: 10.1016/j.amjsurg.2007.09.030.
PubMed 18096127Zaccard CR, Schell RF, Spiegel CA. Efficacy of bilateral bronchoalveolar lavage for diagnosis of ventilator-associated pneumonia. J Clin Microbiol. 2009 Sep;47(9):2918-24. doi: 10.1128/JCM.00747-09. Epub 2009 Jul 15.
PubMed 19605577Esperatti M, Ferrer M, Theessen A, Liapikou A, Valencia M, Saucedo LM, Zavala E, Welte T, Torres A. Nosocomial pneumonia in the intensive care unit acquired by mechanically ventilated versus nonventilated patients. Am J Respir Crit Care Med. 2010 Dec 15;182(12):1533-9. doi: 10.1164/rccm.201001-0094OC. Epub 2010 Aug 6.
PubMed 20693381Bello G, Pennisi MA, Di Muzio F, De Pascale G, Montini L, Maviglia R, Mercurio G, Spanu T, Antonelli M. Clinical impact of pulmonary sampling site in the diagnosis of ventilator-associated pneumonia: A prospective study using bronchoscopic bronchoalveolar lavage. J Crit Care. 2016 Jun;33:151-7. doi: 10.1016/j.jcrc.2016.02.016. Epub 2016 Mar 3.
PubMed 26993370
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilateral Bronchoalveolar Lavage Cultures for Diagnosing Ventilator-associated Pneumonia. Microbiologic Concordance and Impact on the Efficacy of Treatment Decisions.
- ClinicalTrials.gov ID
- NCT02542553
- Acronym / sponsor ID
- Bilateral BAL in VAP
- Conditions
- Pneumonia, Ventilator-Associated
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 7 Sep 2015 (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.
The purpose of this study is to assess microbiologic concordance rates between right- and left-lung bronchoalveolar lavage cultures from patients with suspected ventilator-associated pneumonia, identify predictors of concordance, and evaluate the impact of discordant microbiology on clinicians' ability to prescribe appropriate antibiotic treatments, the investigators conducted a prospective observational study in the general intensive care unit of a large university hospital.
Detailed description
Bronchoscopic sampling of lower respiratory tract secretions is widely used in intensive care units (ICUs) for the microbiological diagnosis of ventilator-associated pneumonia (VAP). However, the importance of selecting a specific lung segment for sampling is still a matter of debate.
Non-bronchoscopic blind mini-bronchoalveolar lavage (BAL) is currently used for the diagnosis of VAP with satisfactory sensitivity and specificity. In the presence of pneumonia, microbiologic concordance between the left and right lungs becomes crucial. If concordance is low, the reliability of blind sampling becomes questionable.
When the bacterial distribution in the right and left lungs of VAP patients has been investigated using bronchoscopic sampling techniques, rates of microbiological concordance between the two specimens have varied widely (from 53% to 92%). The factors potentially associated with concordant culture yields have never been explored, and it is unclear whether the use of guided, bilateral lung sampling would actually improve the appropriateness of the antibiotic regimens prescribed for patients with suspected VAP.
The primary objective of this study is to assess the frequency of microbiologic concordance between the right- and left-lung samples in ICU patients undergoing bronchoscopic BAL performed with two different fiberoptic bronchoscopes for the suspicion of VAP. Secondary objectives are to identify factors associated with such concordance and to evaluate the suitability of treatments prescribed based on unilateral vs. bilateral BAL cultures.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bilateral BAL | Experimental | Procedure: Bilateral BALBronchoscopies are performed in strict accordance with consensus guidelines. The left or right lung is examined with a flexible fiberoptic bronchoscope. If localized infiltrates are present on the chest radiograph, the tip of the scope is wedged into a subsegment of the area displaying the most marked opacity. In the presence of diffuse opacity or when no clear roentgenographic abnormalities are observed, the tip is positioned in the lingula or right middle lobe. Five 20-ml aliquots of sterile normal saline are then injected and reaspirated with a syringe. Bronchoscopy is then repeated in the same manner in the contralateral lung with a second, sterile bronchoscope of the same brand and model. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- invasive mechanical ventilation of ≥ 48 hours
- clinically suspected pneumonia (simplified Clinical Pulmonary Infectious Score exceeded 6 or chest radiographs with a new or progressive pulmonary infiltrate in a patient with at least two of the following: purulent respiratory secretions, temperature >38°C or <36°C, white blood cell count >12,000/mm3 or <4,000/mm3)
Key exclusion criteria (12 listed)
- age <18 years
- pregnancy
- absence of informed consent
- an arterial oxygen partial pressure to inspired oxygen fraction ratio (PaO2:FiO2) of ≤150
- use of positive end-expiratory pressure (PEEP) >10 cmH2O
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 |
|---|---|---|
| Bilateral BAL | Procedure or surgery | Bilateral BAL |
Primary outcome
Rate of microbiologic concordance between the right- and left-lung samples
Time frame: After at least 48 hours of invasive mechanical ventilation
Pneumonia is microbiologically confirmed when the quantitative culture of one or both BAL specimens is positive at significant growth for at least one potential bacterial pathogen. Right and left BAL cultures are classified as concordant when both are positive for the same organism(s) or when neither show any growth. Cultures are classified as discordant when at least one of the microorganisms isolated from one specimen is not recovered from the contralateral specimen.
15 secondary outcomes
Possible association between purulent secretions and microbiologic concordance between right- and left-lung BAL cultures
Time frame: At an expected average of 48 hours after bronchoscopy
Possible association between duration of mechanical ventilation and microbiologic concordance between right- and left-lung BAL cultures
Time frame: At an expected average of 48 hours after bronchoscopy
Possible association between duration of ICU stay and microbiologic concordance between right- and left-lung BAL cultures
Time frame: At an expected average of 48 hours after bronchoscopy
Possible association between duration of hospital stay and microbiologic concordance between right- and left-lung BAL cultures
Time frame: At an expected average of 48 hours after bronchoscopy
Possible association between immunosuppression and microbiologic concordance between right- and left-lung BAL cultures
Time frame: At an expected average of 48 hours after bronchoscopy
Possible association between antibiotic treatment and microbiologic concordance between right- and left-lung BAL cultures
Time frame: At an expected average of 48 hours after bronchoscopy
Possible association between radiological infiltrate and microbiologic concordance between right- and left-lung BAL cultures
Time frame: At an expected average of 48 hours after bronchoscopy
Possible association between body temperature and microbiologic concordance between right- and left-lung BAL cultures
Time frame: At an expected average of 48 hours after bronchoscopy
Possible association between WBC count and microbiologic concordance between right- and left-lung BAL cultures
Time frame: At an expected average of 48 hours after bronchoscopy
Possible association between PaO2:FiO2 and microbiologic concordance between right- and left-lung BAL cultures
Time frame: At an expected average of 48 hours after bronchoscopy
Possible association between PEEP and microbiologic concordance between right- and left-lung BAL cultures
Time frame: At an expected average of 48 hours after bronchoscopy
Possible association between CPIS and microbiologic concordance between right- and left-lung BAL cultures
Time frame: At an expected average of 48 hours after bronchoscopy
Possible association between type of humidification and microbiologic concordance between right- and left-lung BAL cultures
Time frame: At an expected average of 48 hours after bronchoscopy
Possible association between procalcitonin and microbiologic concordance between right- and left-lung BAL cultures
Time frame: At an expected average of 48 hours after bronchoscopy
Possible association between C-reactive protein and microbiologic concordance between right- and left-lung BAL cultures
Time frame: At an expected average of 48 hours after bronchoscopy
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 Sep 2015.
- Results publication: PubMed 1424930Meduri GU, Chastre J. The standardization of bronchoscopic techniques for ventilator-associated pneumonia. Chest. 1992 Nov;102(5 Suppl 1):557S-564S. doi: 10.1378/chest.102.5_supplement_1.557s. No abstract available.
- Results publication: PubMed 8417887Marquette CH, Herengt F, Saulnier F, Nevierre R, Mathieu D, Courcol R, Ramon P. Protected specimen brush in the assessment of ventilator-associated pneumonia. Selection of a certain lung segment for bronchoscopic sampling is unnecessary. Chest. 1993 Jan;103(1):243-7. doi: 10.1378/chest.103.1.243.
- Results publication: PubMed 9731019Meduri GU, Reddy RC, Stanley T, El-Zeky F. Pneumonia in acute respiratory distress syndrome. A prospective evaluation of bilateral bronchoscopic sampling. Am J Respir Crit Care Med. 1998 Sep;158(3):870-5. doi: 10.1164/ajrccm.158.3.9706112.
- Results publication: PubMed 15345979Butler KL, Best IM, Oster RA, Katon-Benitez I, Lynn Weaver W, Bumpers HL. Is bilateral protected specimen brush sampling necessary for the accurate diagnosis of ventilator-associated pneumonia? J Trauma. 2004 Aug;57(2):316-22. doi: 10.1097/01.ta.0000088858.22080.cb.
- Results publication: PubMed 18096127Jackson SR, Ernst NE, Mueller EW, Butler KL. Utility of bilateral bronchoalveolar lavage for the diagnosis of ventilator-associated pneumonia in critically ill surgical patients. Am J Surg. 2008 Feb;195(2):159-63. doi: 10.1016/j.amjsurg.2007.09.030.
- Results publication: PubMed 19605577Zaccard CR, Schell RF, Spiegel CA. Efficacy of bilateral bronchoalveolar lavage for diagnosis of ventilator-associated pneumonia. J Clin Microbiol. 2009 Sep;47(9):2918-24. doi: 10.1128/JCM.00747-09. Epub 2009 Jul 15.
- Results publication: PubMed 20693381Esperatti M, Ferrer M, Theessen A, Liapikou A, Valencia M, Saucedo LM, Zavala E, Welte T, Torres A. Nosocomial pneumonia in the intensive care unit acquired by mechanically ventilated versus nonventilated patients. Am J Respir Crit Care Med. 2010 Dec 15;182(12):1533-9. doi: 10.1164/rccm.201001-0094OC. Epub 2010 Aug 6.
- Derived from this study: PubMed 26993370Bello G, Pennisi MA, Di Muzio F, De Pascale G, Montini L, Maviglia R, Mercurio G, Spanu T, Antonelli M. Clinical impact of pulmonary sampling site in the diagnosis of ventilator-associated pneumonia: A prospective study using bronchoscopic bronchoalveolar lavage. J Crit Care. 2016 Jun;33:151-7. doi: 10.1016/j.jcrc.2016.02.016. Epub 2016 Mar 3.
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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.
Giuseppe Bello, MD principal investigator
Catholic University of the Sacred Heart
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral BAL in people with Pneumonia, Ventilator-Associated, run by Catholic University of the Sacred Heart.
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 2 inclusion and 12 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 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Rate of microbiologic concordance between the right- and left-lung samples (time frame: After at least 48 hours of invasive mechanical ventilation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02542553, which also lists 8 linked publications.
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 Sep 2015.