Evaluating Pressures at the Nares During Non-invasive Ventilation in Newborn Infants Utilizing NIV Plus Software
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- interventions performed while using NIV plus software
研究概览
简要总结
In the past many neonates with respiratory distress syndrome would require intubation, but over the years these rates have declined as the capabilities of non-invasive ventilation (NIV) have vastly improved. Despite these improvements, the decrease in pressure transmission due to factors such as resistance from tubing or air leaks around the nostrils and mouth, continues to be one of the major drawbacks when using nasal NIV. Current ventilators measure the set pressures at the circuit but do not capture the delivered pressure at the patient's nares. Recently, Medtronic PB980 ventilators feature NIV plus and leak sync software that can be calibrated to measure the pressures provided at the nostrils. Optimum pressures received at the nostrils to provide safe and effective therapy in neonates is currently unknown. In the prospective portion of the study, we aim to evaluate safety and efficacy of the software by comparing the average pressure difference between the circuit and delivery pressure at the nares, the incidence of apnea, bradycardia, desaturations as well as escalation and de-escalation of ventilator support in newborns who are receiving NIV admitted to NICU
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 0 Days 至 30 Days(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestation Age of 23-41 weeks
- •Born at LAC+USC Medical Center and admitted to NICU
- •Received NIPPV or nasal CPAP
排除标准
- •Infants with any congenital anomalies
- •Infants receiving only comfort care measures.
- •Infants receiving invasive mode of mechanical ventilation (intubated)
- •Non-inborn neonates
- •Re-admissions to the NICU
结局指标
主要结局
interventions performed while using NIV plus software
时间窗: 24 hours
will study the number of interventions performed when NIV plus software is used
次要结局
- difference in pressures set and received(12 hours)
研究者
Manoj Biniwale
Associate Professor of Pediatrics
Keck School of Medicine of USC
