An interventional study of Bilateral BAL in Pneumonia, Ventilator-Associated, sponsored by Catholic University of the Sacred Heart. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-09-07.
Sponsored by Catholic University of the Sacred Heart · Not applicable, Interventional, and Diagnostic
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.
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.
2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.
This study's enrollment of 79 is below the median of 106 across 1,247 interventional studies indexed under Pneumonia.
Browse Pneumonia studies →Catholic University of the Sacred Heart is the lead sponsor of 227 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Procedure: Bilateral BAL
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.
Time frame: After at least 48 hours of invasive mechanical ventilation
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
Comparison of antibiotic regimens chosen on the basis of right or left-lung culture results alone with regimens chosen on the basis of bilateral culture results, by performing a simulated prescribing experiment.
For each enrolled patient, actual treatment decisions are made by the ICU attending physicians in charge of the case on the basis of the results of bilateral BAL culture and sensitivity analyses. Later, at the end of the study, data for patients with discordant BAL cultures are reviewed in a simulated prescribing session by a second team composed of an ICU physician and an infectious disease specialist. The team is asked to propose an appropriate antimicrobial regimen based on the culture and in vitro antimicrobial susceptibility data for the right-lung BAL sample alone, the left-lung BAL sample alone, and the right and left BAL samples. Each microbiological report is presented separately to the team with a summary of the patient's relevant clinical data. The prescribed regimen is defined as appropriate if it provides active coverage for all of the organisms identified in both BAL specimens.
Time frame: At 18 months after study initiation
No study locations are listed for this record.
This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Catholic University of the Sacred Heart