Oropharyngeal Space in Videolaryngoscopy: a Randomised Crossover Trial Measuring Remaining Space Adjacent to the Videolaryngoscope Blade
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 489
- 试验地点
- 2
- 主要终点
- Palatopharyngeal distance
研究概览
简要总结
In this randomised crossover trial we measure the space between the right side of the laryngoscope blade and the right palatopharyngeal wall in a cohort of ASA I-III patients with a normal mouth opening. We compare the remaining spaces for seven different videolaryngoscopes and compare these to a classic Macintosh laryngoscope.
详细描述
Intubation using indirect videolaryngoscopy has many advantages over classic direct laryngoscopy using the Macintosh laryngoscope. There are many different videolaryngoscopes available, and the blade differs largely between videolaryngoscopes. Different size and angles of blades may have an impact on the space available for insertion of the endotracheal tube. The space between the blade and the palatopharyngeal wall may be reduced significantly, so that there is less room in the mouth to insert an endotracheal tube. Positioning and manoeuvring of the endotracheal tube may consequently be more difficult and may traumatize the pharynx as was described in a few case reports, especially when an endotracheal tube with a rigid stylet inserted was used.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
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
- •Informed patient consent
- •ASA I - III
- •Age > 18 years
- •Elective surgery, other than head and/or neck surgery
- •Pre-operative Mallampati I - III
- •BMI < 35 kg/m2
- •Fasted (≥6 hours)
排除标准
- •No informed patient consent
- •Age < 18 year
- •Emergency surgery, surgery of head and/of neck
- •Locoregional anaesthesia
- •Pre-operative Mallampati IV
- •BMI > 35 kg/m2
- •Fasted < 6 hours
- •Pre-operative expected difficult airway (restrict neck movement, thyromental distance < 65mm, retrognathia)
- •Bad, fragile dentition
- •Dental crowns and/or fixed partial denture
结局指标
主要结局
Palatopharyngeal distance
时间窗: Participants will be followed during induction of anesthesia, an expected average of 10 min
Two laryngoscopes (one classic direct laryngoscope and one indirect videolaryngoscope) will subsequently be inserted into the patient's mouth at random order. With each laryngoscope the horizontal distance between the laryngoscope blade and mid-palatopharyngeal fold will be measured using an mm ruler.
次要结局
- Difference in palatopharyngeal distance between videolaryngoscope and classic Macintosh laryngoscope(Participants will be followed during induction of anesthesia, an expected average of 10 min)
- Difference in palatopharyngeal distance between videolaryngoscopes(Participants will be followed during induction of anesthesia, an expected average of 10 min)
- Cormack-Lehane score(Participants will be followed during induction of anesthesia, an expected average of 10 min)
- Successful intubation(Participants will be followed during induction of anesthesia, an expected average of 10 min)
- Use of rigid stylet(Participants will be followed during induction of anesthesia, an expected average of 10 min)
- Number of attempts(Participants will be followed during induction of anesthesia, an expected average of 10 min)
- Time until picking up endotracheal tube(Participants will be followed during induction of anesthesia, an expected average of 10 min)
- Epiglottic down-folding(Participants will be followed during induction of anesthesia, an expected average of 10 min)
- Complications(Participants will be followed during induction of anesthesia, an expected average of 10 min)
研究者
Barbe Pieters
Principal Investigator
Catharina Ziekenhuis Eindhoven