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临床试验/NCT04326270
NCT04326270Unknown不适用

Crossover Comparison of Tidal Volume Delivery During Nasal Intermittent Positive Pressure Ventilation in Preterm Infants: Infant Cannula vs. Nasal Continuous Positive Airway Pressure Prongs

Arkansas Children's Hospital Research Institute2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年3月7日最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
试验地点
2
主要终点
Relative tidal volume delivery, breath type I

研究概览

简要总结

Crossover bedside clinical study to examine relative tidal volume delivery during nasal intermittent positive pressure ventilation (NIPPV) and directly compare the RAM® infant cannula to a nasal continuous positive airway pressure (nCPAP) delivery system in vivo. The study population will consist of preterm neonates with mild respiratory insufficiency who are receiving NIPPV, non-invasive neurally adjusted ventilatory assist (NIV NAVA), or nCPAP.

详细描述

Bedside crossover study of neonates with mild respiratory distress receiving NIPPV. Infants serve as their own controls and are randomized to initial interface of either RAM® infant cannula or Miniflow® nCPAP prongs. Infants are instrumented with the following monitoring equipment: Edi orogastric tube to measure electrical activity of the diaphragm, transcutaneous monitor to measure transcutaneous CO2 and O2, pulse oximeter to measure heart rate and oxygen saturation, and respiratory inductance plethysmography (RIP) bands around the chest and abdomen to measure breathing movements and relative Vt (arbitrary units, a.u.). Data are continuously and simultaneously acquired using a data acquisition system. After 10 minutes of stabilization, infants receive 5 minutes of NIPPV on each of a sequence of four commonly used pressure settings (expressed as peak inspiratory pressure / positive end expiratory pressure): 16/5, 16/8, 20/5, 20/8. This sequence is not randomized and is constant between interfaces. Subjects are then placed on the alternate interface, and the sequence is repeated. Events ("breaths") are separated into 3 types: patient effort synchronized with NIPPV breaths (type I), NIPPV breaths without patient effort (type II), and patient effort without NIPPV breaths (type III).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
— 至 28 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Chronologic age less than 28 days
  • Gestational age at birth between 24 weeks 0 days to 34 weeks 6 days
  • Currently receiving NIPPV, NIV NAVA, or nCPAP

排除标准

  • Oxygen requirement greater than 40%
  • Peak inspiratory pressure greater than 20 cm H2O
  • Major congenital anomalies of the heart or lungs

结局指标

主要结局

Relative tidal volume delivery, breath type I

时间窗: 1 hour

Relative tidal volume measured in arbitrary units (AU) via RIP bands during synchronized breaths

Relative tidal volume delivery, breath type II

时间窗: 1 hour

Relative tidal volume measured in arbitrary units (AU) via RIP bands during ventilator-driven breaths

Relative tidal volume delivery, breath type III

时间窗: 1 hour

Relative tidal volume measured in arbitrary units (AU) via RIP bands during patient-driven breaths

次要结局

  • Heart rate(1 hour)
  • Ventilator pressure delivery(1 hour)
  • Ventilator flow delivery(1 hour)
  • Oxygen saturation(1 hour)
  • Transcutaneous carbon dioxide tension(1 hour)
  • Transcutaneous oxygen tension(1 hour)

研究者

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

Ashley L. Lynch

Principle Investigator

Arkansas Children's Hospital Research Institute

研究点 (2)

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