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临床试验/NCT02542553
NCT02542553已完成不适用

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

Catholic University of the Sacred Heart0 个研究点目标入组 79 人开始时间: 2013年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
79
主要终点
Rate of microbiologic concordance between the right- and left-lung samples

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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

结局指标

主要结局

Rate of microbiologic concordance between the right- and left-lung samples

时间窗: After at least 48 hours of invasive mechanical ventilation

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.

次要结局

  • 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 PaO2:FiO2 and microbiologic concordance between right- and left-lung BAL cultures(At an expected average of 48 hours after bronchoscopy)
  • Possible association between PEEP and microbiologic concordance between right- and left-lung BAL cultures(At an expected average of 48 hours after bronchoscopy)
  • Possible association between CPIS and microbiologic concordance between right- and left-lung BAL cultures(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(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)
  • Possible association between antibiotic treatment and microbiologic concordance between right- and left-lung BAL cultures(At an expected average of 48 hours after bronchoscopy)
  • Possible association between radiological infiltrate and microbiologic concordance between right- and left-lung BAL cultures(At an expected average of 48 hours after bronchoscopy)
  • Possible association between body temperature and microbiologic concordance between right- and left-lung BAL cultures(At an expected average of 48 hours after bronchoscopy)
  • Possible association between procalcitonin and microbiologic concordance between right- and left-lung BAL cultures(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(At an expected average of 48 hours after bronchoscopy)
  • Possible association between WBC count and microbiologic concordance between right- and left-lung BAL cultures(At an expected average of 48 hours after bronchoscopy)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Giuseppe Bello

Medical doctor

Catholic University of the Sacred Heart

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