NCT00912990终止不适用
Pediatric Elective Intubation With and Without Muscle Relaxation Utilizing the Shikani Optical Stylet
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Time to Intubation
研究概览
简要总结
The investigators' primary specific aims are to demonstrate that:
- Pediatric patients with normal airways, undergoing elective surgical procedures, can be successfully intubated when deeply sedated, without the use of muscle relaxants using the Shikani Optical Stylet.
- Shikani intubation of pediatric patients is equally effective in children that are deeply sedated or paralyzed as evidenced by a non-significant difference in:
- Time to intubation (defined as no more than a 30 second time difference between the two groups);
- Incidence of adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •6 months of age to 17 years of age (not yet 18)
- •Male or female
- •English or Spanish speaking
- •Normal airway (Mallampati Classification )
- •American Society of Anesthesiology Physical Status Classification I or II
- •Elective surgical procedure expected to last at least 45 minutes in length
- •Written informed consent/assent for participation given by the parent legal guardian and subject (if applicable)
排除标准
- •< 6 months of age, > 17 years of age
- •Difficult airway (Mallampati Classification)
- •History of previous difficult intubation, suspected abnormal airway: *micrognathia
- •facial trauma
- •airway tumor
- •epiglottitis
- •retropharyngeal abscess
- •foreign body, etc.
- •Scheduled for non-elective, emergent OR procedure
- •Parent, legal guardian, or subject is unavailable or unwilling to consent for study participation
研究组 & 干预措施
Normal saline
Placebo Comparator
Normal saline volume calculated to be equal to the volume of cisatracurium 0.2mg/kg
干预措施: Normal saline (Drug)
Cisatracurium
Active Comparator
Subjects in this arm will be given Cisatracurium 0.2mg/kg IV dose one time prior to intubation.
干预措施: Cisatracurium (Drug)
结局指标
主要结局
Time to Intubation
时间窗: Confirmed by the visualization of three carbon dioxide waveforms.
Time to intubation was defined as the time (seconds) required to verify three breaths on an end-tidal carbon dioxide monitor.
次要结局
- The Number of Adverse Events(Recorded from the start of the intubation procedure to the time of successful endotracheal intubation)
研究者
Sandeep Khanna
Attending Physician Division of Pediatric Critical Care
Rady Children's Hospital, San Diego
研究点 (1)
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