Bilateral Bronchoalveolar Lavage in Ventilator-associated Pneumonia

NCT02542553 | Completed

• 1 other identifier: Bilateral BAL in VAP
• Study Type: interventional
• Target: 79
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Pneumonia, Ventilator-Associated

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (15)

• Possible association between purulent secretions and microbiologic concordance between right- and left-lung BAL cultures

  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

  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

  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

  At an expected average of 48 hours after bronchoscopy

• Possible association between immunosuppression and microbiologic concordance between right- and left-lung BAL cultures

  At an expected average of 48 hours after bronchoscopy

Other Outcomes (1)

• 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.

  At 18 months after study initiation

Study Arms (1)

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.

Procedure: Bilateral BAL

Interventions

Bilateral BAL PROCEDURE

Bilateral BAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Related Publications (8)

• 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.

  PMID: 1424930 RESULT

• 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;103(1):243-7. doi: 10.1378/chest.103.1.243.

  PMID: 8417887 RESULT

• 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. doi: 10.1164/ajrccm.158.3.9706112.

  PMID: 9731019 RESULT

• 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. doi: 10.1097/01.ta.0000088858.22080.cb.

  PMID: 15345979 RESULT

• 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. doi: 10.1016/j.amjsurg.2007.09.030.

  PMID: 18096127 RESULT

• 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.

  PMID: 19605577 RESULT

• 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;182(12):1533-9. doi: 10.1164/rccm.201001-0094OC. Epub 2010 Aug 6.

  PMID: 20693381 RESULT

• Bello 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.

  PMID: 26993370 DERIVED

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Giuseppe Bello, MD

  Università Cattolica del Sacro Cuore, Rome, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor

Study Record Dates

• First Submitted: August 25, 2015
• First Posted: September 7, 2015
• Study Start: February 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: September 7, 2015

Record last verified: 2015-08