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临床试验/NCT03313947
NCT03313947撤回不适用

Airway Ultrasound to Predict Obstructive Sleep Apnea Syndrome in Children and Its Correlation With Clinical Signs and Symptoms of Obstructive Sleep Apnea

Vidya Raman1 个研究点 分布在 1 个国家开始时间: 2020年3月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
1
主要终点
Hyo-mental distance

研究概览

简要总结

This is a novel approach to assess the use of ultrasound to support the identification of obstructive sleep apnea syndrome (OSAS) on a screening questionnaire, and potentially to predict a difficult pediatric airway. The investigators hope to determine if a combination of simple bedside clinical tests can be used to identify OSAS in patients who present for surgery with clinical signs of OSAS but without a formal polysomnography.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
3 Years 至 12 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •All children presenting for surgery at NCH ranging in age from 3-12 years

排除标准

  • •Parent/ patient refusal to participate in study

研究组 & 干预措施

Difficult Airway

Other

Ultrasound to measure hyo-mental distance, neutral (Frankfort) position, maximal extended neck position to calculate ratio, width of the tongue between the lingual arteries, and tonsillar size (bilateral).

干预措施: Ultrasound (Procedure)

Obstructive Sleep Apnea

Other

Ultrasound to measure hyo-mental distance, neutral (Frankfort) position, maximal extended neck position to calculate ratio, width of the tongue between the lingual arteries, and tonsillar size (bilateral).

干预措施: Ultrasound (Procedure)

Predictive Obstructive Sleep Apnea

Other

The following 6 questions will be asked during the preoperative visit:

  1. While sleeping, does your child snore more than half the time?
  2. While sleeping, does your child always snore?
  3. Have you ever seen your child stop breathing during the night?
  4. Does your child occasionally wet the bed?
  5. Did your child stop growing at a normal rate at any time since birth?
  6. Is your child overweight

干预措施: Questionnaire (Other)

结局指标

主要结局

Hyo-mental distance

时间窗: 5 minutes before surgery starts

The distance from the hyoid bone to the mentum to predict difficult airway.

次要结局

  • Questionnaire(30 minutes before surgery)
  • Tongue width(5 minutes after being intubated in surgery)
  • Tonsil size(5 minutes after being intubated in surgery)

研究者

发起方
Vidya Raman
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Vidya Raman

Clinical Assistant Professor

Nationwide Children's Hospital

研究点 (1)

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