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Bilateral Bronchoalveolar Lavage in Ventilator-associated Pneumonia

Primary Purpose

Pneumonia, Ventilator-Associated

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bilateral BAL
Sponsored by
Catholic University of the Sacred Heart
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pneumonia, Ventilator-Associated

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Bilateral BAL

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Possible association between purulent secretions and microbiologic concordance between right- and left-lung BAL cultures
    Possible association between duration of mechanical ventilation and microbiologic concordance between right- and left-lung BAL cultures
    Possible association between duration of ICU stay and microbiologic concordance between right- and left-lung BAL cultures
    Possible association between duration of hospital stay and microbiologic concordance between right- and left-lung BAL cultures
    Possible association between immunosuppression and microbiologic concordance between right- and left-lung BAL cultures
    Possible association between antibiotic treatment and microbiologic concordance between right- and left-lung BAL cultures
    Possible association between radiological infiltrate and microbiologic concordance between right- and left-lung BAL cultures
    Possible association between body temperature and microbiologic concordance between right- and left-lung BAL cultures
    Possible association between WBC count and microbiologic concordance between right- and left-lung BAL cultures
    Possible association between PaO2:FiO2 and microbiologic concordance between right- and left-lung BAL cultures
    Possible association between PEEP and microbiologic concordance between right- and left-lung BAL cultures
    Possible association between CPIS and microbiologic concordance between right- and left-lung BAL cultures
    Possible association between type of humidification and microbiologic concordance between right- and left-lung BAL cultures
    Possible association between procalcitonin and microbiologic concordance between right- and left-lung BAL cultures
    Possible association between C-reactive protein and microbiologic concordance between right- and left-lung BAL cultures

    Full Information

    First Posted
    August 25, 2015
    Last Updated
    September 3, 2015
    Sponsor
    Catholic University of the Sacred Heart
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02542553
    Brief Title
    Bilateral Bronchoalveolar Lavage in Ventilator-associated Pneumonia
    Official Title
    Bilateral Bronchoalveolar Lavage Cultures for Diagnosing Ventilator-associated Pneumonia. Microbiologic Concordance and Impact on the Efficacy of Treatment Decisions.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2013 (undefined)
    Primary Completion Date
    July 2014 (Actual)
    Study Completion Date
    July 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Catholic University of the Sacred Heart

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pneumonia, Ventilator-Associated

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    79 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Bilateral BAL
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Bilateral BAL
    Primary Outcome Measure Information:
    Title
    Rate of microbiologic concordance between the right- and left-lung samples
    Description
    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
    Secondary Outcome Measure Information:
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Other Pre-specified Outcome Measures:
    Title
    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.
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Giuseppe Bello, MD
    Organizational Affiliation
    Università Cattolica del Sacro Cuore, Rome, Italy
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    1424930
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    8417887
    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;103(1):243-7. doi: 10.1378/chest.103.1.243.
    Results Reference
    result
    PubMed Identifier
    9731019
    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. doi: 10.1164/ajrccm.158.3.9706112.
    Results Reference
    result
    PubMed Identifier
    15345979
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    18096127
    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. doi: 10.1016/j.amjsurg.2007.09.030.
    Results Reference
    result
    PubMed Identifier
    19605577
    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.
    Results Reference
    result
    PubMed Identifier
    20693381
    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;182(12):1533-9. doi: 10.1164/rccm.201001-0094OC. Epub 2010 Aug 6.
    Results Reference
    result
    PubMed Identifier
    26993370
    Citation
    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.
    Results Reference
    derived

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    Bilateral Bronchoalveolar Lavage in Ventilator-associated Pneumonia

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