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临床试验/NCT04800198
NCT04800198已完成不适用

Intraoral Measurement of Pressure in Preterm Infants

University Medical Center Goettingen1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
24
试验地点
1
主要终点
Median Pressure reached by any tape of non-invasive ventilation

研究概览

简要总结

The aim of the study is to show pressure curves in the nasopharynx in non-invasively ventilated and spontaneously breathing premature and newborn babies

详细描述

The aim of the investigation is to show the pressure curves in the nasopharynx in non-invasively ventilated and spontaneously breathing premature and newborn babies, with a number large enough for an analysis. For this purpose, the pressure in the nasopharynx of these children is to be measured using a suction catheter, as is usually used to suction off mucus and saliva, and the measured values are to be evaluated with software. This method is a tried and tested method in adults for measuring the pressure conditions in the nasopharynx, which was developed and used by Mr. Olthoff. A possible later clinical application in premature and newborn infants ranges from the measurement of breathing and ventilation to manual control of respiratory support depending on the measured value to automatic triggering and control of a ventilator in the sense of nSIPPV ventilation (non-invasive synchronized intermittent positive pressure ventilation )

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
3 Days 至 3 Months(Child)
性别
All
接受健康志愿者

入选标准

  • newborns, non-invasive ventilation

排除标准

  • Bad clinical condition of the patient (e.g. sepsis)
  • Bleeding tendency
  • Anatomical peculiarities that make it difficult to insert the suction catheter through the nose (e.g. choanal atresia)
  • Lack of acceptance of the probe by the child
  • Proven infection / colonization of the child by a multi-resistant germ (MRGN 2-4, MRSA) or with noro- / adenoviruses
  • Missing / withdrawn consent by the legal guardians

结局指标

主要结局

Median Pressure reached by any tape of non-invasive ventilation

时间窗: 1 year

The pressure reached by non-invasive ventiation (nCPAP or HFT) in neonates of any gestation is measured weekly to collect data on how to correctly set the ventilator.

次要结局

未报告次要终点

研究者

发起方
University Medical Center Goettingen
申办方类型
Other
责任方
Principal Investigator
主要研究者

Helmut Küster

MD, Principal Investigator

University Medical Center Goettingen

研究点 (1)

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