跳至主要内容
临床试验/NCT04659083
NCT04659083已完成不适用

How NAVA Works in Preterm Infants With Irregular Respiratory Efforts

Inha University Hospital1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2020年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
18
试验地点
1
主要终点
the amount of backup breaths by the ventilator

研究概览

简要总结

For the infant participating the study, ventilator settings and respiratory variables will be recorded every day and exported to a specific computer using the Servo Record Viewer version 1.0 (Maquet Critical Care AB, Getinge, Gothenburg, Sweden). Collected data gives the value for peak inspiratory pressure (PIP), expiratory tidal volume (Vt), peak Edi, minimum Edi, measured respiratory rate (RR), neural respiratory rate (nRR) and percentage of backup breaths for each minute. All the ventilator data will be inspected and compared with the event logs recorded automatically from the ventilator, which includes all the alarm notification, mode and setting changes, cables connection and disconnection data. Data during disconnection of the Edi cable, malfunction or dislocation of Edi catheter will be excluded from the analysis. The mean values during each day will be computed for each ventilatory variables. If there is a change in the ventilatory setting parameters, we will choose the one which was applied for longer duration in the 24-hour time period.

The following clinical characteristics will be collected from medical records: gestational age at birth, birth weight, gender, the time and amount of feeding, medication during the study days, desaturation events, bradycardia events, suction time and methods.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
0 Days 至 36 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • babies who receiving respiratory support with neurally adjusted ventilatory assist
  • babies with informed consents from their parents

排除标准

  • babies using anesthetic agents

结局指标

主要结局

the amount of backup breaths by the ventilator

时间窗: during the respiratory support using NAVA, from day 1 until the end of 36 weeks of postmenstrual age

% time of backup/min according to babies' weight, postmenstrual age and postnatal age

次要结局

未报告次要终点

研究者

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

Juyoung Lee

Professor

Inha University Hospital

研究点 (1)

Loading locations...

相似试验

How NAVA Works in Preterm Infants With Irregular... | 临床试验