Randomized Control Trial Comparing the Effect of PEEP Titration using LOW-PEEP/HIGH-FIO2 Table with Conventional Method of PEEP titration in Pediatric Acute Respiratory Distress Syndrome.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To assess the changes in oxygenation index at the end of 48 hrs
研究概览
简要总结
This is a Randomised control trial to compare the predesigned table (low PEEP/High FiO2 table)with conventional method of peep titration available, in children.This is our pilot effort to establish the clinical utility of this table in deciding the Pressure adjustment during mechanical ventilation. We will be comparing this technique with conventional method followed in our hospital.
Current status of the study (interim analysis ) total 37 children were recruited till now.19 children were randomised to LOW-PEEP HIGH-FIO2 table group , while 18 were in the conventional PEEP titration there was a significant change in Oxygenation Index (OI) across different time points (At Zero , 12 , 24 , 36, and 48hrs), regardless of arm membership (P-value for Time = 0.026). The two arms did not significantly differ in OIacross all time points (P-value for Arm = 0.204). Similarly,there was a significant change in PaO2/FiO2 (PF) ratio across same different time points, regardless of arm membership (P-value for Time <0.001). The two arms did not have significantdifference in PF ratio across all time points (P-value for Arm = 0.229).There was no significant difference between driving pressure , mechanical power, plateau pressure and dead space fraction between the two arms at 48hours.There was no difference in incidence of air leaks, hemodynamic instability and pulmonary bleeds between the two groups.
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 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Invasively ventilated children more than 1 month and up to 18 years age with pARDS diagnosed as per PALICC-2.
排除标准
- •Children who are not intubated
- •Children who are already on High Frequency Oscillatory ventilation.
- •Children with open chest (following surgery)
- •Children with raised Intra cranial pressure
- •children with post cardiac arrest, neuromuscular disorder, congenital heart disease, mechanical ventilation of more than 1-week, uncontrolled terminal illness,
- •Previous barotrauma (pneumothorax, pneumomediastinum or subcutaneous emphysema)
- •When treating consultant refuses to participate (Due to unacceptable Vt, hemodynamic instability, radiological/ clinical evidence of lung hyperinflation).
结局指标
主要结局
To assess the changes in oxygenation index at the end of 48 hrs
时间窗: To assess the changes in oxygenation index at the end of 48 hrs
次要结局
- 28-Day ventilation Free days and Mortality difference between the groups.(28 days)
- 28-Day ventilation Free days and Mortality difference between the groups.(• 28- day ventilator free days,)
研究者
Dr Farhan Shaikh
Rainbow Childrens Hospital