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临床试验/NCT03785977
NCT03785977已完成不适用

A Prospective Comparison of the Airway Deadspace Associated With the Air-Q® and Endotracheal Tube Using Volumetric Capnography in Young Children

Wake Forest University Health Sciences1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2019年3月25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
62
试验地点
1
主要终点
Mean Value of Airway Dead Space

研究概览

简要总结

The objective of this study will be to measure the airway deadspace associated with use of appropriately sized an AirQ, a commonly used supraglottic airway in young children weighing between 5 and 20 kg and compare that to the airway deadspace associated with use of an endotracheal tube (ETT) in similarly sized children undergoing controlled ventilation.

详细描述

There is an increasing interest in the use of supraglottic airway devices in progressively younger and younger patients. One issue that has not been well evaluated is the contribution of these devices to airway dead space in young children and infants. Volumetric capnography is the only non-invasive technology available at the current time to evaluate airway deadspace. Volumetric capnography essentially monitors the flow of CO2 over time and from the expired waveform one can determine different respiratory parameters including dead space. This is clinically important in young children as the clinician begins to evaluate whether or not to use an endotracheal tube or supraglottic airway in these patients. To perform this investigation the study team will use volumetric capnography to examine the airway dead space associated with these devices during and elective general surgery and urologic procedures in healthy children between the ages of 0 and 6 years of age (roughly 5-20 kg).

Participants in the study will be given ETT or Air-Q as an intervention, but the investigator does not assign specific interventions to the study participants.

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 Months 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients between the ages of 3 months and 6 years of age weighing between 5 and 20 kg
  • Patient presenting outpatient urologic or general surgery

排除标准

  • History of difficult airway/intubation
  • Patients suspected to have a difficult airway.
  • Morbid obesity BMI >39
  • Emergency status of surgery
  • Patients exposed to second hand smoke
  • Patients with Asthma
  • Patients with a URI symptom such as nasal drainage, cough, or fever within 7 days of the date of surgery
  • History of Prematurity

结局指标

主要结局

Mean Value of Airway Dead Space

时间窗: 10 minutes

A mean value observed over the first 10 minutes following placement of the ETT or the AirQ at the beginning of the case will be recorded.

次要结局

  • Lung Compliance measured by Respironics NM3 respiratory monitors(10 minutes)
  • Volume of Carbon Dioxide Associated with the Devices(10 minutes)
  • Airway Resistance measured by Respironics NM3 respiratory monitors(10 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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