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临床试验/NCT00938002
NCT00938002已完成不适用

Rapid Bacterial Identification and Antibiotic Resistance Testing in Critically Ill Adults at Risk for Ventilator Acquired Pneumonia (VAP).

Denver Health and Hospital Authority1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2009年7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
37
试验地点
1
主要终点
Reduction in time to diagnosis and treatment of VAP in an at risk population

研究概览

简要总结

Critically ill patients on a breathing machine are at risk of developing a type of pneumonia called Ventilator Acquired Pneumonia (VAP). The purpose of this study is to determine if regular lung rinses sent for microbiological testing can reduce the time to diagnose VAP. The study also plans to test the accuracy and speed of a new technology, using multiplexed automated digital microscopy, to identify the germs causing the VAP.

详细描述

Ventilator-associated pneumonia (VAP) is a common, life-threatening hospital-acquired infectious complication of prolonged mechanical ventilation (MV). Despite aggressive efforts to prevent VAP, rates remain high because clinical diagnosis is imprecise and microbiological diagnosis is frequently delayed. Diagnosis of VAP depends on clinical signs as well as microbiologic evidence from Bronchioalveolar Lavage (BAL) cultures. Ordinarily, these cultures are only ordered after the patient presents with clinical signs and symptoms of VAP, which can significantly delay diagnosis and effective therapy. This research proposes to implement additional surveillance BAL cultures in order to reduce the time to diagnosis of VAP in mechanically ventilated critically ill adults. To further reduce the time to diagnosis of VAP, this research aims to test part of the BAL cultures using a novel flowcell/surface-capture device that allows direct from specimen visualization of bacteria using multiplexed automated digital microscopy (BACcel™) for rapid bacterial identification and antibiotic resistance testing. Additionally, molecular assays of the BAL sample will characterize lower respiratory tract antimicrobial peptide host-innate immune molecule and local anti-oxidant defenses in mechanically ventilated adults at risk for VAP.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

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

  • Written, informed consent (by surrogate if unconscious or if altered mental status)
  • ≥ 18 years old
  • Admission to a Medical Intensive care unit
  • Orally/nasally intubated, evaluable within 72 h of initial intubation
  • Expected to remain mechanically ventilated for at least 48 h after the first study procedure

排除标准

  • Previously documented cystic fibrosis
  • Diffuse bronchiectasis
  • Severe or massive hemoptysis
  • Presence of an advanced directive to withhold life-sustaining treatment
  • Morbid state or expected to survive less than 14 days because of an advanced co-morbid medical condition
  • Participation in a clinical trial of any unlicensed drug or device within 30 days
  • Pregnant or Nursing

结局指标

主要结局

Reduction in time to diagnosis and treatment of VAP in an at risk population

时间窗: 30 days

次要结局

未报告次要终点

研究者

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

Ivor Douglas

Chief, Pulmonary Sciences & Critical Care Medicine

Denver Health and Hospital Authority

研究点 (1)

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