Bilateral Bronchoalveolar Lavage in Ventilator-associated Pneumonia

Pneumonia, Ventilator-Associated Clinical Trial

Official title:

Bilateral Bronchoalveolar Lavage Cultures for Diagnosing Ventilator-associated Pneumonia. Microbiologic Concordance and Impact on the Efficacy of Treatment Decisions.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02542553
• Other study ID #: Bilateral BAL in VAP
• Status: Completed
• Phase: N/A
• First received: August 25, 2015
• Last updated: September 3, 2015
• Start date: February 2013
• Est. completion date: July 2014

Study information

• Verified date: August 2015
• Source: Catholic University of the Sacred Heart
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical 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 appropriate antibiotic treatments, the investigators conducted a prospective observational study in the general intensive care unit of a large university hospital.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

• 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Ventilator-Associated

Intervention

Procedure:
• Bilateral BAL

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

References & Publications (7)

Butler 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. — View Citation

Esperatti 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;1 — View Citation

Jackson 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. — View Citation

Marquette 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;1 — View Citation

Meduri GU, Chastre J. The standardization of bronchoscopic techniques for ventilator-associated pneumonia. Chest. 1992 Nov;102(5 Suppl 1):557S-564S. Review. — View Citation

Meduri 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. — View Citation

Zaccard 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	At 18 months after study initiation	No
Primary	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.	After at least 48 hours of invasive mechanical ventilation	No
Secondary	Possible association between purulent secretions and microbiologic concordance between right- and left-lung BAL cultures		At an expected average of 48 hours after bronchoscopy	No
Secondary	Possible association between duration of mechanical ventilation and microbiologic concordance between right- and left-lung BAL cultures		At an expected average of 48 hours after bronchoscopy	No
Secondary	Possible association between duration of ICU stay and microbiologic concordance between right- and left-lung BAL cultures		At an expected average of 48 hours after bronchoscopy	No
Secondary	Possible association between duration of hospital stay and microbiologic concordance between right- and left-lung BAL cultures		At an expected average of 48 hours after bronchoscopy	No
Secondary	Possible association between immunosuppression and microbiologic concordance between right- and left-lung BAL cultures		At an expected average of 48 hours after bronchoscopy	No
Secondary	Possible association between antibiotic treatment and microbiologic concordance between right- and left-lung BAL cultures		At an expected average of 48 hours after bronchoscopy	No
Secondary	Possible association between radiological infiltrate and microbiologic concordance between right- and left-lung BAL cultures		At an expected average of 48 hours after bronchoscopy	No
Secondary	Possible association between body temperature and microbiologic concordance between right- and left-lung BAL cultures		At an expected average of 48 hours after bronchoscopy	No
Secondary	Possible association between WBC count and microbiologic concordance between right- and left-lung BAL cultures		At an expected average of 48 hours after bronchoscopy	No
Secondary	Possible association between PaO2:FiO2 and microbiologic concordance between right- and left-lung BAL cultures		At an expected average of 48 hours after bronchoscopy	No
Secondary	Possible association between PEEP and microbiologic concordance between right- and left-lung BAL cultures		At an expected average of 48 hours after bronchoscopy	No
Secondary	Possible association between CPIS and microbiologic concordance between right- and left-lung BAL cultures		At an expected average of 48 hours after bronchoscopy	No
Secondary	Possible association between type of humidification and microbiologic concordance between right- and left-lung BAL cultures		At an expected average of 48 hours after bronchoscopy	No
Secondary	Possible association between procalcitonin and microbiologic concordance between right- and left-lung BAL cultures		At an expected average of 48 hours after bronchoscopy	No
Secondary	Possible association between C-reactive protein and microbiologic concordance between right- and left-lung BAL cultures		At an expected average of 48 hours after bronchoscopy	No