Comparison of Endotracheal Tube With Subglottic Suction Drainage With Standard Endotracheal Tube in the Incidence of Airway Colonization and Ventilator Associated Pneumonia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Incidence of Ventilator Associated Pneumonia
研究概览
简要总结
Ventilator Associated Pneumonia (VAP) is associated with increased hospitalisation, increased health care cost and high morbidity and mortality. The incidence of VAP increases with duration of mechanical ventilation. There is limited data especially from India on the incidence of VAP and also the role of subglottic aspiration in its prevention. The aim of this study is to determine the role of subglottic suction in the incidence of VAP.
详细描述
Patients will be enrolled following inclusion-exclusion criteria
- Base line clinical and laboratory data will be recorded in a pre designed proforma.
- Endotracheal aspirate will be taken at the time of enrollment and day3, day5, day7 and then weekly till patient is on mechanical ventilation.
Data collection
For each patient following data will be recorded as per the proforma.
During Hospitalization
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age more than 18 years
- •Requiring orotracheal intubation and mechanical ventilation
排除标准
- •Patients intubated outside the hospital
- •Patient extubated within 72 hours
- •Patient already on tracheostomy
- •Death occurring within 72 hours
- •Pneumonia developing within 48 hours
- •Patient/relatives not giving consent
研究组 & 干预措施
SSD Arm
In the SSD arm, the patients will be intubated with an endotracheal tube with suglottic suction drainage (SSD tube)
干预措施: SSD tube (Device)
Standard Arm
In the standard arm, the patients will be intubated with the standard endotracheal tube which does not have subglottic suction.
结局指标
主要结局
Incidence of Ventilator Associated Pneumonia
时间窗: 28 days
To assess the role of endotracheal tube with subglottic suction drainage on incidence of VAP as compared to standard ET tube
Incidence of airway colonization
时间窗: 28 days
Assess the incidence of airway colonization during the period of endotracheal intubation
次要结局
未报告次要终点
研究者
Vijay Noel Nongpiur
Senior Resident
All India Institute of Medical Sciences, New Delhi