Assessment of the GlideScope Spectrum Video Laryngoscope Blades and Stylet for Use in Neonate & Pre-Adolescent Populations: Pilot Manikin Study
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
- 1
- 主要终点
- Time to intubate
研究概览
简要总结
The overall purpose of this study is to assess the functionality & impact of the use of the newly designed GlideScope Spectrum pediatric video laryngoscope and stylet for the orotracheal intubation of neonates and pediatric patients, utilizing manikin models.
详细描述
The overall purpose of this study is to assess the functionality & impact of the use of the newly designed GlideScope Spectrum pediatric video laryngoscope blades and stylet for the orotracheal intubation of neonates and pediatric patients, utilizing manikin models. The hypothesis is that the Spectrum laryngoscope blades and stylet can improve the time and/or success of orotracheal intubation in a manikin.
Secondary aims of this study include assessing the impact of Spectrum pediatric video laryngoscope blades under simulated normal and difficult airway conditions on glottic view grade, mouth space, ease of blade insertion, ease of tracheal tube insertion, mechanisms of tracheal tube insertion impediment, and perceived overall clinical & functional usefulness in airways with predictors of difficult intubation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Anesthesia and emergency medicine providers who perform pediatric orotracheal intubations
- •Able to give voluntary consent to participate in the study
- •Are experienced with orotracheal intubation (> 50 times) using direct laryngoscopy or video laryngoscopy
排除标准
- •Volunteers who are < 18 years of age
- •Volunteers unable to read or understand English
- •Unable to physically meet the demands of orotracheal intubation or those who have heart, wrist, or low back disease. Are not experienced with pediatric orotracheal intubations
结局指标
主要结局
Time to intubate
时间窗: 120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt.
Time to intubate on each of 3 attempts per blade, on each manikin type.
First pass success rate
时间窗: 120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt.
First pass success rate on each of 3 attempts per blade, on each manikin type. First pass success (FPS) is defined as the ability to place a tracheal tube below a patient's vocal cords on the first attempt without removing the video laryngoscope from the patient's mouth.
Overall performance and clinical utility using a 5-point Likert Scale
时间窗: 120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt.
Overall performance and clinical utility of single-use pediatric stylet; Using a 5-point LIKERT SCALE, participants will grade the following statements with regards to the use of the single-use pediatric stylet 1. = strongly disagree 2. = disagree 3. = neutral 4. = agree 5. = strongly agree e.g. - Participants will assign a number to the following statements: * The pediatric style was easy to insert into the mouth of the when used with normal neonate manikin * The pediatric style was easy to insert into the mouth of the when used with the difficult neonate manikin * The pediatric style was easy to insert into the mouth of the when used with normal pediatric manikin
次要结局
- Failed intubation attempt(120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt.)
- Intubation success on first attempt(120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt.)