Clinical trial NCT02542553: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pneumonia, Ventilator-Associated
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2015-09-07
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Rate of microbiologic concordance between the right- and left-lung samples
timeFrame: After at least 48 hours of invasive mechanical ventilation
Secondary outcomes:
measure: Possible association between purulent secretions and microbiologic concordance between right- and left-lung BAL cultures
timeFrame: At an expected average of 48 hours after bronchoscopy
measure: Possible association between duration of mechanical ventilation and microbiologic concordance between right- and left-lung BAL cultures
timeFrame: At an expected average of 48 hours after bronchoscopy
measure: Possible association between duration of ICU stay and microbiologic concordance between right- and left-lung BAL cultures
timeFrame: At an expected average of 48 hours after bronchoscopy
measure: Possible association between duration of hospital stay and microbiologic concordance between right- and left-lung BAL cultures
timeFrame: At an expected average of 48 hours after bronchoscopy
measure: Possible association between immunosuppression and microbiologic concordance between right- and left-lung BAL cultures
timeFrame: At an expected average of 48 hours after bronchoscopy
measure: Possible association between antibiotic treatment and microbiologic concordance between right- and left-lung BAL cultures
timeFrame: At an expected average of 48 hours after bronchoscopy
measure: Possible association between radiological infiltrate and microbiologic concordance between right- and left-lung BAL cultures
timeFrame: At an expected average of 48 hours after bronchoscopy
measure: Possible association between body temperature and microbiologic concordance between right- and left-lung BAL cultures
timeFrame: At an expected average of 48 hours after bronchoscopy
measure: Possible association between WBC count and microbiologic concordance between right- and left-lung BAL cultures
timeFrame: At an expected average of 48 hours after bronchoscopy
measure: Possible association between PaO2:FiO2 and microbiologic concordance between right- and left-lung BAL cultures
timeFrame: At an expected average of 48 hours after bronchoscopy
measure: Possible association between PEEP and microbiologic concordance between right- and left-lung BAL cultures
timeFrame: At an expected average of 48 hours after bronchoscopy
measure: Possible association between CPIS and microbiologic concordance between right- and left-lung BAL cultures
timeFrame: At an expected average of 48 hours after bronchoscopy
measure: Possible association between type of humidification and microbiologic concordance between right- and left-lung BAL cultures
timeFrame: At an expected average of 48 hours after bronchoscopy
measure: Possible association between procalcitonin and microbiologic concordance between right- and left-lung BAL cultures
timeFrame: At an expected average of 48 hours after bronchoscopy
measure: Possible association between C-reactive protein and microbiologic concordance between right- and left-lung BAL cultures
timeFrame: At an expected average of 48 hours after bronchoscopy
Other outcomes:
measure: 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.
timeFrame: At 18 months after study initiation
Locations:
Study officials:
affiliation: Università Cattolica del Sacro Cuore, Rome, Italy
name: Giuseppe Bello, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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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.
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.
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.
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.