Intraoral Measurement of Pressure in Preterm Infants
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
- 否
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- •Missing / withdrawn consent by the legal guardians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
Helmut Küster
MD, Principal Investigator
University Medical Center Goettingen
