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临床试验/NCT01902446
NCT01902446已完成不适用

A Pilot Study of Prehospital Oral Chlorhexidine Gluconate to Prevent Early Ventilator Associated Pneumonia in Intubated Trauma Patients

Nicholas M Mohr1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2013年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
70
试验地点
1
主要终点
Clinical Pulmonary Infection Score (CPIS)

研究概览

简要总结

Traumatic injury in rural America is a significant cause of morbidity and mortality, and the challenges of a rural trauma system can put patients at unique risk. Prolonged transport times to a trauma center, stopping for care at referring hospitals, and longer exposure to care-associated factors distinguish rural patients from their urban counterparts. Ventilator-associated pneumonia (VAP) is a significant risk in rural patients, increasing hospital stay, healthcare costs, and even mortality in the critically injured. The investigators propose a pilot study to test the hypothesis that a single dose of oral chlorhexidine gluconate (antiseptic) for trauma patients in the prehospital environment will decrease subsequent development of early VAP. Chlorhexidine is currently a standard therapy in intensive care units to prevent airway colonization and subsequent development of VAP. Demonstrating safety and effectiveness of prehospital infection control practices could significantly improve outcomes of traumatic injury in rural America.

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

  • Adults (age >= 18 years)
  • Endotracheal intubation
  • Transported by air ambulance
  • Traumatic injury
  • Interfacility transport (no flights from scene) en route to University of Iowa Hospitals and Clinics)

排除标准

  • Known or suspected pregnancy
  • Prisoners
  • Patients diagnosed with pneumonia prior to transfer
  • Known allergy to chlorhexidine gluconate
  • Surgical airway (tracheostomy or cricothyroidotomy)
  • Massive aspiration
  • Anticipated nonsurvivable injury (survival projected < 24 hours)

研究组 & 干预措施

Chlorhexidine gluconate

Intubated subjects transported by one air service will be treated with 5 mL chlorhexidine gluconate 0.12% applied for at least 30 seconds during helicopter transport.

干预措施: Chlorhexidine gluconate (Drug)

结局指标

主要结局

Clinical Pulmonary Infection Score (CPIS)

时间窗: 48-72 hours

次要结局

  • Pneumonia - CPIS(5 days)
  • Pneumonia - Treated(5 days)
  • Pneumonia - Research(5 days)
  • Hospital Mortality(28-days)
  • Tracheostomy Rate(28 days)
  • Pneumonia - CDC(5 days)
  • 28-day ventilator-free days(28 days)
  • 28-day ICU-free days(28 days)
  • Tracheal colonization(48-72 hours)

研究者

发起方
Nicholas M Mohr
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Nicholas M Mohr

Assistant Professor of Emergency Medicine and Anesthesia Critical Care

University of Iowa

研究点 (1)

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