Determination by a Noninvasive Method of the Geometric Dimensions of the Nasal Cavities of the Premature Newborn
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Minimal cross sectional area measured by acoustic rhinometry
研究概览
简要总结
During the resuscitation of preterm infants, withdrawal of non-invasive ventilation is difficult. In a recent study in children gestational age <30 weeks of amenorrhea (SA), definitive withdrawal rate from the first attempt to stop the non-invasive ventilation was 32% . In the same study, the median number of attempts before achieving a final withdrawal was 3 for children born before 28 weeks. The reasons for weaning failure are multiple and little studied. It seems that the type of interface used, mask or cannula, having an influence on the effectiveness of non-invasive ventilation . The nasal lesions induced by non-invasive ventilation are not uncommon, regardless of the interface used . In a recent randomized trial, they ranged from 40% to 50% depending on the type of nasal cannula and non-invasive ventilation mode. It is in this case external damage. But we assume that the breakdown causes internal lesions dependent on the pressure, humidity and flow. These factors are likely to generate a nasal obstruction, source intervention nurses who aspire nasal passages more or less traumatic.
The nasal cavities are often abused and, because of their key role in breathing, could be involved in the withdrawal of ventilatory failure
详细描述
The measurements of the nasal cavity dimensions are carried out by acoustic rhinometry (about 10 seconds for an acquisition). Measurement of nasal resistance is performed by rhinomanometry earlier (about a minute to a measure). They may be made to wakefulness or sleep since they do not require their participation. These measures will be carried at birth and then every 7 to 10 days (before the age of 28 days), if the child is still hospitalized.
During these measurements, the heart rate and oxygen saturation are collected by a measuring sensor transcutaneously.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Affiliation to social security
- •Informed Parental Consent
- •Newborns term and preterm
- •Age less than or equal to 28 days
- •Signature of informed consent by both parents
排除标准
- •craniofacial malformation
- •Dyspnea (Silverman score> 3)
- •severe sepsis
- •life-threatened
结局指标
主要结局
Minimal cross sectional area measured by acoustic rhinometry
时间窗: during the hospitalization of the infants, from birth to week 8
Acoustic rhinometry is a functional non-invasive procedure based on the sound reflection of acoustic waves on the nasal cavities. This procedure allows determining the geometry and the size of nasal cavities. The device is composed by a wave tube connected to a sound generator emitting series of acoustic impulsions. On this wave tube are laterally connected 2 microphones, themselves connected with a computer which analyzes the acoustic signal. These microphones detect the acoustic reflected wave.
次要结局
未报告次要终点
研究者
Claude Danan
Doctor
Centre Hospitalier Intercommunal Creteil