跳至主要内容
临床试验/CTRI/2025/03/082865
CTRI/2025/03/082865尚未招募3 期

Incidence of ventilator associated pneumonia in open tracheal suction system versus closed tracheal suction system in mechanically ventilated children, An open label randomized controlled trial

All India Institute of Medical Sciences Jodhpur1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年3月31日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
150
试验地点
1
主要终点
To compare the incidence of ventilator associated pneumonia after 48 hour of endotracheal intubation in pediatric patients randomly allocated to OTSS versus CTSS.

研究概览

简要总结

Ventilator-associated pneumonia (VAP) emerges as a hospital-acquired infection affecting the lower respiratory tract in individuals on mechanical ventilation, typically manifesting >or = 48 hours after ventilation initiation. Its correlation with prolonged ventilator reliance, extended stays in intensive care and hospitals, increased mortality rates, and substantial financial burdens is evident.

Infants and children on artificial airways necessitate endotracheal suctioning to clear secretions and avert airway blockages. Within pediatric intensive care units (PICUs), twoprimary suctioning systems are used commonly: open endotracheal suctioning (OES), which requires disconnection using single-use catheters, and closed-system suctioning (CSS), utilizing multiple-use in-line catheters that permit uninterrupted mechanical ventilation during suctioning. CSS proposes potential advantages including enhanced physiological stability and reduced infection risks by eliminating environmental contamination of the catheter before its introduction into the endotracheal tube and by limiting the dispersal of infectious mucus particles. Despite these suggestions, the recommendation of CSS as a preventive measure for pediatric VAP lacks substantial supporting evidence.

Despite meta-analyses and randomized controlled trials revealing no significant disparities between OES and CSS in VAP occurrence among adults and neonates, clear evidence in the pediatric age group is presently lacking.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
1.00 Month(s) 至 17.00 Year(s)(—)
性别
All

入选标准

  • Children between one month to 17 years receiving mechanical ventilation for ≥48 hours.
  • Parents or guardians giving informed written consent for enrollment of child into study.

排除标准

  • Children who are transferred to our hospital already intubated.

结局指标

主要结局

To compare the incidence of ventilator associated pneumonia after 48 hour of endotracheal intubation in pediatric patients randomly allocated to OTSS versus CTSS.

时间窗: To compare the incidence of ventilator associated pneumonia after 48 hour of endotracheal intubation in pediatric patients randomly allocated to OTSS versus CTSS.

次要结局

  • To compare the duration of mechanical ventilation(At 4 weeks, earlier/later until the child is intubated)
  • To compare the PICU mortality in each group(At 4 weeks, earlier/later until the child is discharged from PICU)
  • To compare the hospital mortality in each group(At 4 weeks, earlier/later until the child is discharged from hospital)
  • Length of PICU stay(At 4 weeks, earlier/later until the child is discharged from PICU)
  • Length of hospital stay(At 4 weeks, earlier/later until the child is discharged from hospital)

研究者

发起方
All India Institute of Medical Sciences Jodhpur
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Rajwant Singh Gautam

All India Institute of Medical Sciences Jodhpur

研究点 (1)

Loading locations...

相似试验

Comparison of two different suction techniques in... | 临床试验