EFFECT OF VARYING LEVELS OF PEEP ON PRETERM LUNG RECRUITMENT USING ELECTRICAL IMPEDANCE TOMOGRAPHY- FEASIBILITY STUDY
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Changes in EIT parameters
研究概览
简要总结
Babies born early (under 32 weeks) are at risk of developing lung problems after birth. A major reason for this is that the lungs are not fully developed. Lungs of preterm babies will often collapse in between breathing due to lung immaturity. Applying gentle pressure, using nasal device through their nostril or through the breathing tube helps to prevent this lung collapse. This would help in air-oxygen going to lungs and also makes the babies breathing more comfortable. This gentle pressure is medically called as PEEP/CPAP and could be delivered by breathing machine (ventilator) and CPAP machine, collectively called as "continuous distending pressure (CDP)".
Those babies breathing on their own and receiving inadequate CDP would need more breathing support by placing them on breathing machine (ventilator). The longer the baby receives breathing machine support, higher chance of lung injury . Preterm infants who are already on breathing machine, providing sub optimal PEEP/CPAP could also lead to lung damage. Providing optimal PEEP/CPAP could prevent these negative outcomes. Currently there is not enough evidence to suggest optimal PEEP/CPAP in preterm infants. Neonatal units all around the world uses PEEP/CPAP ranging from 4 to 10cm H20 based on their unit practice. Currently available investigations provide limited one time information (e.g. Chest X-ray) regarding whether baby is receiving optimal PEEP/CPAP. Electrical Impedance Tomography (EIT) is a new technology which could provide better information regarding the pressure delivered. Also, this device would provide continuous information as if the clinicians are doing continuous chest X-ray but without any radiation. In this study, the team will assess the effect of different levels of PEEP/CPAP (4 to 10cm H20) on prevention of lung collapse using EIT. This would be studied in premature infants who are on breathing machine support and CPAP machine support.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 22 Weeks 至 32 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age <32 weeks based on mother's last menstrual period or first trimester ultrasound dating.
- •Receiving either CPAP or mechanical ventilation respiratory support.
- •Informed written consent from one of the parents.
- •Within the first two weeks of life. Investigators pragmatically chose this period, as there could be considerable lung injury after the first two weeks of life, making it difficult to test our hypothesis. Also, this time period would allow parents to settle down with their stressful preterm delivery and investigators could approach anytime within the first two weeks of life.
排除标准
- •Major congenital malformations including congenital lung disease and congenital heart disease as ascertained by the medical team.
- •Infants diagnosed with pneumothorax i.
- •Receiving high frequency mechanical ventilation.
- •Infants with concerns of skin integrity.
研究组 & 干预措施
Single arm with increasing and decreasing PEEP levels
干预措施: Studying the effects of varying levels of PEEP using Electrical impedance tomography (Diagnostic Test)
结局指标
主要结局
Changes in EIT parameters
时间窗: 280minutes
Changes in functional lung scores in percentage varying levels of CDP.
Changes in EIT
时间窗: 280 minutes
Changes in silence spaces with varying levels of CDP.
Changes in EIT parameters
时间窗: total study of 280 minutes
Changes in End expiratory Lung Impedance scores
次要结局
- Secondary outcomes(Total 280 minutes of study time)
- Secondary outcome measure(Total study time of 280 minutes)
- Secondary outcome(Total study time of 280minutes)
- Secondary outcome(Total study time of 280 minutes)