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临床试验/NCT04546087
NCT04546087已完成不适用

Impact of Labor and Delivery on Ultrasound Measured Cricothyroid Membrane Depth and Height

Samuel Lunenfeld Research Institute, Mount Sinai Hospital2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
2
主要终点
Cricothyroid membrane position change

研究概览

简要总结

The cricothyroid membrane acts as a route through which the upper airway can be accessed to provide oxygen and ventilation to patients. Anesthesiologists need to deliver oxygen and ventilation to patients under general anesthesia, where patients may lose the ability to breath for themselves. Access through this membrane to provide oxygen and ventilation is critical in emergency situations where other traditional means to access the airway (e.g. through endotracheal ventilation, supraglottic airway devices or face mask ventilation) have failed. It is known, from previous studies, that due to the physiological changes that occur in labour, the upper airway of the body undergoes changes that can make accessing the airway through traditional means more difficult, specifically during the period of labor, delivery, and just after delivery. Ultrasound is becoming increasingly popular due to its ability both to identify the cricothyroid membrane and to improve success in accessing the airway through the cricothyroid membrane. What is not known, and has not been studied to date, is specifically how the anatomy (i.e. its height and its depth) specifically changes during the period of labour, delivery and just after delivery.

The aim of this study would be to scan (using ultrasound) pregnant women's necks once at the very start of their labour, and once within 4 hours of delivery of their baby, to identify how the size and depth of the cricothyroid membrane changes. This information would improve the understanding of how to best approach accessing this membrane in laboring pregnant women.

The investigators hypothesize that in labouring third trimester patient, that the depth to the cricothyroid membrane will increase, and there will be no change in the cricothyroid membrane height.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age >=18 years old
  • Pregnant patients in third trimester (>28/40 weeks)
  • Ability to understand the rationale of the study assessments and to provide signed consent.

排除标准

  • Neck arthritis
  • Cervical stenosis
  • Known cervical degenerative disc disease
  • Rheumatoid Arthritis
  • Any restriction of neck movement
  • Upper limb neurology
  • Patient refusal
  • Patients not in established labour.
  • Patients undergoing cesarean section
  • Known distorted airway anatomy

研究组 & 干预措施

Ultrasound

Experimental

Ultrasound measurements of the cricothyroid membrane.

干预措施: Ultrasound (Device)

结局指标

主要结局

Cricothyroid membrane position change

时间窗: 24 hours

Difference between the depth from the skin to the cricothyroid membrane- tracheal interface change ultrasound between the onset of established labor and following delivery of the baby and placenta.

次要结局

  • Cricothyroid membrane size change(24 hours)

研究者

发起方
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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