跳至主要内容
临床试验/CTRI/2011/06/001840
CTRI/2011/06/001840暂停3 期

Role of subglottic suctioning in the prevention of ventilator associated pneumonia in critically ill patients requiring invasive mechanical ventilation in a tertiary care hospital in South India.

Christian Medical College1 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2011年1月7日最近更新:
适应症

试验速览

阶段
3 期
状态
暂停
入组人数
320
试验地点
1
主要终点
Incidence of Ventilator associated pneumonia.

研究概览

简要总结

This study is to assessthe role of subglottic suctioning in patients requiring mechanical ventilationin the Medical ICU.  As a part ofstandard care in intubated patients, the secretions from the respiratory tract areperiodically suctioned through the endotracheal tube using sterile suctioncatheters. However it was shown in multiple observational studies that thesubglottic space between the vocal cords and the bulb of the ET tube harbors apool of secretions that are not accessible for routine suctioning. This pool ofsecretions forms a focus for colonization of various bacteria which are shownto be responsible for Ventilator Associated Pneumonia (VAP). VAP prolongs theduration of ICU stay as well the mortality of the patient.  Also the financial burden due to a VAP is notonly the cost of additional ICU stay but also the second line antibiotics whichare often used in its treatment.

The central idea of thisstudy is an intervention enabling the clearance of the subglottic pool ofsecretions and its ability in prevention of VAP. Patients will be randomized toget either routine endotracheal suctioning alone or subglottic suctioning inaddition to the routine endotracheal suctioning. Subglottic suctioning is donethrough a port which opens into the subglottic region in specially designed ETtubes. Multiple randomized control trials world over have shown benefit withsubglottic suctioning in the prevention of VAP, however data from a developingcountries is lacking. We aim to show improved rates of VAP per ventilator days.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 80.00 Day(s)(—)
性别
All

入选标准

  • •All patients requiring Medical ICU admission for invasive mechanical ventilation will be recruited into the study.

排除标准

  • •Patients who are intubated elsewhere and are referred to CMC for admission are excluded from the trial.
  • •Patients admitted to ICU for Non-invasive ventilation alone are excluded.
  • •Tracheostomised patients are excluded.

结局指标

主要结局

Incidence of Ventilator associated pneumonia.

时间窗: During the ICU stay.

次要结局

  • Time to VAP diagnosis(Mortality rate)

研究者

申办方类型
Private medical college

研究点 (1)

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