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临床试验/NCT06161389
NCT06161389已完成不适用

Applied Forces During Neonatal Face Mask Ventilation With Different Face-mask Air Cushion

University Hospital Padova2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2023年12月11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
28
试验地点
2
主要终点
Applied forces on the manikin face

研究概览

简要总结

Positive pressure ventilation (PPV) is the most important intervention in neonatal resuscitation. During PPV, it is important to hold the face-mask with care, as applying excessive pressure could cause injury to the infant, while insufficient pressure could be a contributor of mask leak and reduced effective ventilation. Application of positive pressure to face structures may trigger a vagally mediated reflex via the trigeminal nerve that innervates the skin of the face leading to apnoea and a decrease in heart rate (TCR, trigeminal-cardiac reflex).

In neonatal manikins, ventilation with a partially or fully inflated face mask does not seem to result in differences in mask leak. The force exerted by providers to improve mask seal might result in pressure lesions and in the elicitation of the trigeminal-cardiac reflex. However, information about the applied forces is unknown.

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
25 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Level III NICU consultants and pediatric residents

排除标准

  • 未提供

结局指标

主要结局

Applied forces on the manikin face

时间窗: 1 minute

The forces applied by the participants to the manikin face will be measured by sensors positioned on the manikin face

次要结局

  • Cuff pressure(1 minute)
  • Percentage of ventilation time with leak less than 25% around the mask(1 minute)

研究者

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

Daniele Trevisanuto

Associate Professor

University Hospital Padova

研究点 (2)

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