跳至主要内容
临床试验/NCT03153241
NCT03153241已完成不适用

Value of Subglottic Secretion Culture in Predicting Microbial Flora of Tracheal Secretions in Intubated Patients. A Prospective Observational Study

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年10月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Number of patients with the same pathogens in both subglottic secretions and endotracheal aspirates

研究概览

简要总结

Ventilator-associated pneumonia (VAP) continues to be a major cause of morbidity and mortality in the intensive care unit (ICU). Microaspiration of subglottic secretions accumulated above the endotracheal tube cuff is the primary route of bacterial entry into the lower respiratory tract.Therefore, removal of secretions from the subglottic spacehas been recommended as a preventive strategy to avoid microaspiration and VAP. In this context, whereas considerable literature exists on the use subglottic secretion drainage (SSD) in patients at risk for developing VAP, there is a lack of data on the bacterial growth in the subglottic fluid above the cuff.

The primary objective of the study will be to assess the value of subglottic secretion culture in predicting microbial flora of endotracheal aspirate samplein patients admitted to our ICU and under invasive mechanical ventilation for at least 48 hours. Secondary end-point will be to estimate the predictive value of subglottic secretion culture in identifying bacterial pathogens in the sub-population of patients who will develop VAP.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • ≥18 years of age
  • Invasive mechanical ventilation for at least 48 hours

排除标准

  • age <18 years
  • absence of informed consent
  • pregnancy
  • documented treatment-limitation orders in the patient's chart

结局指标

主要结局

Number of patients with the same pathogens in both subglottic secretions and endotracheal aspirates

时间窗: 6 months

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

Dr. Gennaro De Pascale

Dr Giuseppe Bello (Principal-Investigator)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

研究点 (1)

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