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临床试验/NCT03266380
NCT03266380Unknown不适用

Risk Factors and Common Preventive Measures for Ventilator Associated Pneumonia in Patients With Severe Traumatic Brain Injury

Assiut University0 个研究点目标入组 80 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
80
主要终点
Risk factors and common preventive measures for ventilator associated pneumonia in patients with severe traumatic brain injury Risk factors and common preventive measures for ventilator associated pneumonia in patients with severe traumatic brain injury

研究概览

简要总结

The primary objective of this study is to assess the incidence of VAP in patients with TBI and to identify risk factors for developing VAP in this specific patient population (types of co-injuries in patients with multiple trauma or characteristics on admission). The secondary objective is to assess the prevalence of pathogens responsible for early- and late-onset VAP in patients with TBI. The tertiary objective is to discuss the ability of preventive measures to reduce the incidence of VAP

详细描述

Ventilator-associated pneumonia (VAP) is a type of nosocomial pneumonia that occurs in patients who receive >48 h of mechanical ventilation (MV). Early onset VAP occurs during the first 4 days of MV and is usually caused by antibiotic-sensitive bacteria. The increased systemic inflammatory response in patients with a head trauma may predispose them to develop early-onset VAP1,2. Late-onset VAP develops 5 days after initiating MV and is caused by multidrug resistant (MDR) pathogens3,4.

Patients with traumatic brain injury (TBI) are at high risk of infection, particularly nosocomial infections, during treatment in the intensive care unit (ICU) 5-7, where the incidence of VAP can be as high as 50%. The duration of MV usually influences the type of organism that causes VAP8. Early-onset VAP is caused by antibiotic-sensitive pathogens, whereas late-onset VAP is caused by MDR bacteria, which are more difficult to treat. The microbiological environment can have a marked influence on VAP isolates, particularly during late-onset VAP, but it also influences early-onset VAP9. Patients who acquire VAP have longer ICU stays, higher morbidity and mortality, and a greater number of infectious agents10,11. The risk factors for developing VAP are diverse, and the pathogenesis of intra-hospital infections is complex. Common VAP preventive measures such as early mobility, the daily interruption of sedation, and a readiness-to-extubate assessment may not be applicable because of associated injuries such as severe chest trauma, intra-abdominal bleeding, and other organ damage. Hence, VAP diagnosis can be difficult in a setting of multiple trauma, and significant variations in the diagnosis and management of VAP remain8.

The upper respiratory tract of the majority of mechanically-ventilated patient is colonized with potentially pathogenic microorganisms. This was first established in a study in 1969 that reported the presence of enteric gram-negative bacteria in the oropharynx of 75 percent of critically ill patients8. A proposed explanation is bacterial overgrowth of the upper gastrointestinal tract and retrograde movement. Aspiration of secretions containing these pathogens provides a means for infection of the sterile bronchial tree. Another study published in 2007 confirmed the presence of similar pathogenic microorganisms in the lower respiratory tract of intubated patients by comparing DNA samples from bacteria on the tongue and obtained from bronchoalveolar lavage (BAL)12.

Prevention of VAP:

The use of Non-invasive positive pressure ventilation NPPV has been shown to significantly lower the risk of VAP and has also demonstrated a mortality benefit in randomized studies conducted using patients with a variety of illnesses10, daily weaning trials and sedation holidays have been repeatedly described and validated as strategies that limit the time of mechanical ventilation13,14.

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
10 Years 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • - All patients with TBI who are on MV for >48 h after the initial evaluation.
  • Patients are transferred either from the emergency room directly to the ICU, or they are transferred to the operating room first and are then admitted to the ICU after surgery.
  • Patients intubated outside the hospital and who had no side effects are also included.

排除标准

  • - Patients with documented gastric aspiration, recent antibiotic therapy, 2 days of hospitalization in the preceding 30 days, residence in a nursing home or extended care facility, home therapy, or an underlying malignancy are excluded.
  • Patients who are transferred within the hospital if there was an accident or change in the ventilator system, or who have other known risk factors for developing pneumonia, are also excluded.

结局指标

主要结局

Risk factors and common preventive measures for ventilator associated pneumonia in patients with severe traumatic brain injury Risk factors and common preventive measures for ventilator associated pneumonia in patients with severe traumatic brain injury

时间窗: all patients admitted to general or trauma ICU in assiut university hospital will be recorded from january 2018 to december 2018

The patients are divided into three groups, as follows: patients who donot develop VAP, those who develop early onset VAP, and those who develop late-onset VAP • The primary objective of this study is to assess the incidence of VAP in patients with TBI and to identify risk factors for developing VAP in this specific patient population (types of co-injuries in patients with multiple trauma or characteristics on admission). The secondary objective is to assess the prevalence of pathogens responsible for early- and late-onset VAP in patients with TBI. The tertiary objective is to discuss the ability of preventive measures to reduce the incidence of VAP.

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

mohamed mahmoud abdelaziz

specialist at anesthesia and ICU department

Assiut University

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