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临床试验/CTRI/2017/04/008290
CTRI/2017/04/008290尚未招募不适用

To compare the effect of early vs. late tracheostomy tube change on the incidence of infection in Traumatic Brain Injury patients in ICU.

未提供1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2017年4月18日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
80
试验地点
1
主要终点
Incidence of infection

研究概览

简要总结

Respiratory tract infections are the most common nosocomial infections encountered in ICU patients. Common source of these infections are indwelling tubes and catheters. Despite of the aseptic and hygiene practices by the ICU staff there has been only a moderate decrease in the infection rate.In  earlier studies tube were changed after 7 days. Biofilms are formed within 7 days of insertion but colonization begins as early as 12 hr and most abundant in 96 hr.  So we hypothesized that changing of tracheostomy tube within 96 hr to prevent further biofilm formation and reduces subsequent acquired infection.

After obtaining written informed consent from patient guardian or relative,  patients will be divided randomly into two groups (n=40): Group E tracheostomy tube changed on every 4th day; Group L tracheostomy tube will be changed on every 7th day. Baseline parameter of infection like fever, TLC and culture report  are documented. Tracheal aspirate culture will be send before tube change along with culture of blood, urine or any other potential source of infection. Any raise in temperature and TLC will be documented. Antibiotcs will be changed based on culture and sensitive report.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1.Head injury patients on tracheostomy tube.
  • 2.Age group between 18 and 60 years.

排除标准

  • 1.Patients on immunosuppressant’s.
  • 2.Patients transferred from other ICU.
  • 3.Pregnancy.
  • 5.Patient refusal to participate in the study.
  • 6.Patient on adrenoreceptor agonist or antagonist therapy.
  • 7.Uncontrolled medical disease (diabetes mellitus and hypertension).
  • 8.Patient already in sepsis.

结局指标

主要结局

Incidence of infection

时间窗: Group E 7,11,15 day | Group L 7,14,21 day

次要结局

  • Type of micro-organism isolated.(Group E 7,11,15 days)

研究者

发起方
未提供

研究点 (1)

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