Weekly Versus no Routine Ventilator Circuit Changes in Neonatal Intensive Care Unit: Prospective, Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- incidence of ventilator-associated pneumonia (percentage of ventilator-associated pneumonia (events)/mechanically ventilated infant)
研究概览
简要总结
The purpose of this study is to determine incidence of ventilator-associated pneumonia compared between weekly and no routine ventilator circuit changes in neonatal intensive care unit
详细描述
Parents were received informed consent. Enrolled neonates was randomly assigned to 2 groups as 7-day ventilator circuit change and no change group by computerization with allocated of concealment. The investigation team opened the next sequentially numbered study pack, which was stored in the neonatal unit. The assignment sequence was generated with balance within random block sizes of 4. Stratification according to birthweight was done before randomization to control for differences in patient populations. Patient characteristics were recorded as gestational age, sex, birthweight, underlying disease, date of intubation, date of extubation, duration of mechanical ventilator, reintubation, length of hospital stay, parenteral nutrition, medication (H2-blocker, PPI, narcotic drugs), transfusion and oral immune therapy. Laboratory data and radiographic data were recorded. Both groups received similarly care as the nurse was assigned to take care of patient in ratio 1-2 patients: 1 nurse, new disposable circuits were use in both groups and the VAP prevention protocol and the endotracheal suctioning protocol which followed by an American Academy of Respiratory Care (AARC) clinical practice guidelines were performed in both groups.
When the VAP was suspected the radiographic data were reviewed by two pediatric radiologists on the day of diagnosis, 3 days prior to the diagnosis and/or 2 and 7 days after diagnosis to confirm diagnosis of VAP if there is different in the results, the consensus must be made.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 1 Year(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All neonates who admitted at neonatal intensive care unit (NICU) and required ventilator support with both intubated at time of neonatal resuscitation and within the NICU as indicated
排除标准
- •Patient was extubated or died within 2 calendar days of endotracheal intubation
- •Pneumonia was diagnosed before intubation
- •Outborn who was intubated before referred
- •Parents declined to participate
- •Incompatibility of disposable circuits and ventilator
- •Chromosome abnormality or moribund
结局指标
主要结局
incidence of ventilator-associated pneumonia (percentage of ventilator-associated pneumonia (events)/mechanically ventilated infant)
时间窗: within the first 30 days (plus or minus 7 days) after extubation
percentage of ventilator-associated pneumonia (events)/mechanically ventilated infant
次要结局
- incidence of ventilator-associated pneumonia (ventilator-associated pneumonia (events)/1,000 ventilator days)(within the first 30 days (plus or minus 7 days) after extubation)
- Mortality rate(within the first 30 days (plus or minus 7 days) after discharge)
研究者
Anucha Thatrimontrichai
Mr
Prince of Songkla University
