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临床试验/NCT01488370
NCT01488370已完成不适用

A Comparison of the Glidescope® Video Laryngoscope and the Storz DCI® Video Laryngoscope for Endotracheal Intubation in Children Younger Than Two Years of Age

Loma Linda University4 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2011年11月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
65
试验地点
4
主要终点
Measurement of Time to Intubation Will Begin at the Time of Mouth Opening and End With the Removal of the Tip of the Laryngoscope Blade From the Patient's Mouth After Successful Endotracheal Intubation.

研究概览

简要总结

This is a prospective randomized clinical study to be performed in pediatric patients under the age of 2 years who are undergoing surgical procedures requiring endotracheal intubation. Time to endotracheal intubation will be compared between patients intubated using a GlideScope® video laryngoscope, those intubated with a Storz DCI® video laryngoscope, and those intubated by standard direct laryngoscopy. The study hypothesis is that the time to endotracheal intubation will be decreased in the Storz DCI® video laryngoscope group when compared to the GlideScope® video laryngoscope group and standard laryngoscopy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
— 至 23 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Pediatric patients under the age of 2 years undergoing surgeries requiring endotracheal intubation at LLUMC will be eligible for participation in this study

排除标准

  • Children with increased pulmonary aspiration risk;
  • Prior documentation of difficult endotracheal intubation;
  • Those that lack legal representative consent

研究组 & 干预措施

Glidescope

Active Comparator

A device for endotracheal intubation.

干预措施: Endotracheal intubation (Device)

Storz

Active Comparator

A device for endotracheal intubation.

干预措施: Endotracheal intubation (Device)

Standard Laryngoscope

Active Comparator

A device for endotracheal intubation

干预措施: Endotracheal intubation (Device)

结局指标

主要结局

Measurement of Time to Intubation Will Begin at the Time of Mouth Opening and End With the Removal of the Tip of the Laryngoscope Blade From the Patient's Mouth After Successful Endotracheal Intubation.

时间窗: Less than one day, representing the day of surgery and period of endotracheal intubation during induction of general anesthesia

次要结局

  • Successful Intubation After Three Laryngoscopy Attempts(Less than one day, representing the day of surgery and period of endotracheal intubation during induction of general anesthesia.)
  • Successful Intubation After One Laryngoscopy Attempt(Less than one day, representing the day of surgery and period of endotracheal intubation during induction of general anesthesia.)
  • Successful Intubation After Two Laryngoscopy Attempts(Less than one day, representing the day of surgery and period of endotracheal intubation during induction of general anesthesia.)
  • Successful Intubation After Four Laryngoscopy Attempts(Through endotracheal intubation during induction of general anesthesia, an average of 10 minutes)

研究者

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

Elizabeth Ghazal

MD

Loma Linda University

研究点 (4)

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