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临床试验/NCT05961683
NCT05961683尚未招募不适用

Evaluating Pressures at the Nares During Non-invasive Ventilation in Newborn Infants Utilizing NIV Plus Software

Keck School of Medicine of USC2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年8月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Manoj Biniwale

Associate Professor of Pediatrics

Keck School of Medicine of USC

研究点 (2)

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