Rapid Bacterial Identification and Antibiotic Resistance Testing in Critically Ill Adults at Risk for Ventilator Acquired Pneumonia (VAP).
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
- 否
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
Ivor Douglas
Chief, Pulmonary Sciences & Critical Care Medicine
Denver Health and Hospital Authority
