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临床试验/NCT00893763
NCT00893763已完成2 期

Oral Care Intervention in Mechanically Ventilated Adults

University of South Florida2 个研究点 分布在 1 个国家目标入组 314 人开始时间: 2008年9月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
314
试验地点
2
主要终点
Development of VAP (Clinical Pulmonary Infection Score)

研究概览

简要总结

Ventilator-associated pneumonia (VAP) is a serious complication in mechanically ventilated critically ill patients. The intervention tested in this project (swabbing the mouth with chlorhexidine before the endotracheal tube is inserted) could reduce the risk of ventilator-associated pneumonia.

详细描述

Ventilator-associated pneumonia (VAP) is an acute care complication with high morbidity and mortality, which is costly in length of stay and resources used. Application of chlorhexidine (CHX) to the mouths of critically ill adults after intubation reduces risk of VAP. During intubation, organisms may be dragged by the tube from the contaminated mouth to the sterile lung, and the endotracheal tube (ET) provides a pathway for direct entry of bacteria from the mouth to the lower respiratory tract. However, procedures to decontaminate the mouth before intubation are not routine and little is known about the effects of pre-intubation CHX in critically ill patients. Thus, this project focuses on evaluating the benefit of adding a pre-intubation CHX dose to the known benefit of post-intubation CHX to reduce the risk of VAP. In order to examine the effect of pre-intubation CHX on early ET colonization, we will perform microbial cultures of ETs of subjects who are extubated in the first 24 hours of study participation. We will also explore selected biomarkers (procalcitonin, cytokines) as indicators of development of VAP in a subset of subjects. The project will add to knowledge about the relationships among oral health, ET intubation and VAP, and addresses an important clinical outcome. Pre-intubation oral decontamination could reduce risk of VAP and its associated morbidity and mortality.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

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

  • Need for intubation

排除标准

  • Pneumonia at the time of intubation

结局指标

主要结局

Development of VAP (Clinical Pulmonary Infection Score)

时间窗: Baseline up to 5 days

Change between post-intervention CPIS and baseline CPIS. Serial prospective evaluation of VAP risk. 6 elements of CPIS (tracheal secretions, temperature, white blood count, oxygenation, chest radiograph, and tracheal aspirate culture) summed to yield total score of 0-12 daily; higher score reflects greater likelihood of VAP.

次要结局

  • Endotracheal Tube Colonization(24 hours)
  • Serum Cytokines(5 days)
  • Serum Procalcitonin(5 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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