Applied Forces During Neonatal Intubation With Direct and Video Laryngoscopy at Different Heights of the Resuscitation Table: a Randomized Crossover Manikin Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 32
- 主要终点
- Magnitide of applied forces (Newton)
研究概览
简要总结
The study aims to compare the applied forces during intubation of a newborn manikin with direct and video laryngoscope at different heights of the resuscitation table. Furthermore, the success at the first attempt, the intubation time and participants' opinion on the procedures were investigated.
This is an unblinded, randomized, controlled, crossover trial on the applied forces during intubation of a newborn manikin with direct and video laryngoscope at different heights of the resuscitation table.
详细描述
Background: Endotracheal intubation is an important life-saving procedure for critically ill neonates. Some procedure-related aspects may affect the quality of the intubation. Optimizing the relative height between patient and operator may improve intubation procedures.
Objectives: To compare the applied forces during intubation of a newborn manikin with direct and video laryngoscope at different heights of the resuscitation table. Furthermore, the success at the first attempt, the intubation time, and participants' opinions on the procedures were investigated.
Methods: This is an unblinded, randomized, controlled, crossover trial on the applied forces during intubation of a newborn manikin with direct and video laryngoscope at different heights of the resuscitation table. Participants will be Level III NICU/PICU consultants, and pediatric residents. Randomization will be performed using a computer-generated random assignment list. The primary outcome measure will be the forces applied on the neonatal manikin during the intubation. The secondary outcome measures will be the success of the first attempt, the total time of intubation, and participants' opinions about the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Level III NICU and PICU consultants, and pediatric residents
排除标准
- •Refusal to participate
研究组 & 干预措施
Direct laryngoscope and table at xiphoid level
Participants will be required to intubate the manikin with a direct laryngoscope and table at xiphoid level
干预措施: Direct laryngoscope and table at xiphoid level (Device)
Videolaryngoscope and table at xiphoid level
Participants will be required to intubate the manikin with a video laryngoscope and table at xiphoid level
干预措施: Videolaryngoscope and table at xiphoid level (Device)
Direct laryngoscope and table at umbilical level
Participants will be required to intubate the manikin with a direct laryngoscope and table at umbilical level
干预措施: Direct laryngoscope and table at umbilical level (Device)
Videolaryngoscope and table at umbilical level
Participants will be required to intubate the manikin with a video laryngoscope and table at umbilical level
干预措施: Videolaryngoscope and table at umbilical level (Device)
结局指标
主要结局
Magnitide of applied forces (Newton)
时间窗: 3 minutes
Magnitude of forces (measured in Newton) applied to the epiglottis and the palate of the neonatal manikin during the intubation
次要结局
- Percentage of participants achieving the intubation success at the first attempt(30 seconds)
- Total time of intubation(3 minutes)
- Participant's opinions about the procedure(12 hours)
研究者
Daniele Trevisanuto
Associate Professor
University Hospital Padova